| Primary | Serum Progesterone (P4) Level in the Morning of the Day of Human Chorionic Gonadotrophin (hCG) Administration | Ovulation induction was performed by administration of hCG once three follicles >=17 mm diameter as shown by pelvic ultrasound examination. This outcome compares the serum progesterone level the morning prior to hCG administration across treatment arm, and also by age stratum (<39 years and >=39 years). | | Posted | | Mean | Standard Deviation | ng/ml | | approximately day 10 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Menotrophin: Stratum Age <39 Yrs | The subset of participants in the menotrophin treatment arm who were < 39 years old. | | OG002 | Menotrophin: Stratum Age >=39 Yrs | The subset of participants in the menotrophin treatment arm who were >= 39 years old. | | OG003 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG004 | Follitrophin Alpha: Stratum Age <39 Yrs | The subset of participants in the follitrophin alpha treatment arm who were < 39 years old. | | OG005 | Follitrophin Alpha: Stratum Age >=39 Yrs | The subset of participants in the follitrophin alpha treatment arm who were >= 39 years old. |
| | Units | Counts |
|---|
| Participants | - OG00062
- OG00150
- OG00212
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.69± 0.34
- OG0010.72± 0.35
- OG0020.54± 0.25
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | t-test, 2 sided | | 0.003 | The significance level is 0.05. | | | | | | 95 | | | | | | No | Superiority or Other | | | | | t-test, 2 sided | |
|
| Secondary | Receiver Operating Characteristic (ROC) Analysis of Progesterone as Predictor for Ongoing Pregnancy Rate at Day 7 and Day of hCG Administration | The influence of the progesterone level on the ongoing pregnancy rate (in relation to all randomized patients) was determined by means of the receiver operating characteristic (ROC) curve. Youden's Index (sensitivity + specificity -1) has a range of 0-1, with 0.5 indicating a random effect. | | Posted | | Number | | Youden's index | | Day 7, approximately Day 10 (hCG Administration) | | | | ID | Title | Description |
|---|
| OG000 | All Participants | The analysis of whether progesterone level is a predictor for ongoing pregnancy used all participants. |
| |
| Secondary | Percentage of Participants With Ongoing Pregnancy | Ongoing pregnancy is defined as having a positive foetal heart action nine or more weeks after the first positive pregnancy test. | The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint). | Posted | | Number | | percentage of participants | | approximately 3.5 months from study start (at least 9 weeks after first positive pregnancy test) | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Number of Follicles at hCG Administration | Number of follicles >=17 mm diameter detected by pelvic ultrasound examination at day of hCG administration. | The per-protocol (PP) set of participants with non-missing values. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint). | Posted | | Mean | Standard Deviation | follicles | | approximately day 10 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Average Follicle Diameter at hCG Administration | | The per-protocol (PP) set of participants with non-missing values. | Posted | | Mean | Standard Deviation | mm | | approximately day 10 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Number of Cumulus-oocyte Complexes Retrieved | Cumulus-oocyte complexes are oocytes with surrounding cumulus cells. | The per-protocol (PP) set of participants with non-missing values. | Posted | | Mean | Standard Deviation | oocytes | | approximately day 12 after study start | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Number of Pronuclear Oocytes | Pronuclear oocytes are fertilized oocytes. | The per-protocol (PP) set of participants with non-missing values. | Posted | | Mean | Standard Deviation | oocytes | | approximately day 13 after study start | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Number of Participants With Pronuclear Stage Oocytes at Each Quality Grade | The count of participants with different quality grades of pronuclear stage oocytes is offered. Pronuclear stage oocytes are categorized into seven grades (0A, 0B, 1-5) representing different patterns of pronuclear morphology, according to the German Pronuclear Morphology Study Group. 0A is the highest quality oocyte and grade 5 is the lowest quality. Participants can have pronuclear stage oocytes of different grades and therefore are counted more than once. | The per-protocol (PP) set -- defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint). | Posted | | Number | | participants | | approximately day 13 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
|
| Secondary | Number of Embryos Transferred | Mean number of embryos transferred 2-3 days following oocyte retrieval. | The per-protocol (PP) set who had embryos transferred. PP set is defined as participants of the full analysis set without any major protocol violation (i.e., any deviation which was likely to bias the assessment of the primary endpoint). | Posted | | Mean | Standard Deviation | embryos | | approximately day 14 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Best Quality of an Embryo Transferred | Embryo quality was measured by the following grades:
- Grade 1: Evenly sized cells, regular cleavage, no fragmentation
- Grade 2: Regular or slightly irregular cleavage, <=20% fragmentation
- Grade 2.5: Regular or slightly irregular cleavage, >20%and <=50% fragmentation
- Grade 3: Irregular cleavage, >50% fragmentation, >1 intact cell
- Grade 4: Extensive fragmentation, only 1 cell intact
- Grade 5: Totally fragmented, no viable cells.
Grade 1 represents the healthiest embryos and Grade 5 embryos are not viable. | Per protocol set of participants who had embryos transferred | Posted | | Number | | participants | | approximately day 14 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
|
| Secondary | Number of Frozen Oocytes at Pronuclear Stage | No more than three normally developed embryos were transferred 2-3 days after oocyte retrieval. Other normally developed embryos were frozen. | Per protocol set of participants who had embryos transferred | Posted | | Mean | Standard Deviation | oocytes | | approximately day 14 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Endometrial Thickness on Day of hCG Administration | Endometrial thickness was assessed by pelvic ultrasound on the day of hCG administration. | Per protocol set of participants. One participant in the Follitrophin Alpha arm was missing a measurement. | Posted | | Mean | Standard Deviation | mm | | approximately day 10 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Estradiol (E2) Levels on Day of hCG Administration | | Per protocol set. Five participants from each treatment arm were missing blood samples. | Posted | | Mean | Standard Deviation | ng/ml | | approximately day 10 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Percentage of Participants With Successful Embryo Transfer | | | Posted | | Number | | percentage of participants | | approximately day 18 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Number of Days Stimulated With Gonadotrophins | Number of days in which gonadotrophins were administered until hCG criteria were met. If hCG criteria were not met by day 13, the participant was withdrawn from the study. | | Posted | | Mean | Standard Deviation | days | | Day 1 up to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Number of Ampoules of Gonadotrophins Used | Number of ampoules of gonadotrophins used with the goal of reaching hCG criteria. Each ampoule contained 75 IU of either menotrophin or follitrophin alpha. | | Posted | | Mean | Standard Deviation | ampoules | | Day 1 up to Day 12 | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Percentage of Participants With Clinical Pregnancy 6 Weeks After the First Positive Pregnancy Test | A pelvic ultrasound scan was performed approximately 6 weeks after the first positive pregnancy test and the presence of an active foetal heart action indicated a clinical pregnancy. | | Posted | | Number | | percentage of participants | | approximately 2.5 months from start of study, 6 weeks after first positive pregnancy test | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |
| Secondary | Summary of Pregnancy Outcome | Pregnancy outcomes were reported at the optional long-term follow up visit. | Per protocol set of participants who reported information during the optional long-term follow up visit. | Posted | | Number | | participants | | up to 10 months | | | | ID | Title | Description |
|---|
| OG000 | Menotrophin | Menotrophin 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. | | OG001 | Follitrophin Alpha | Follitrophin alpha 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met. Pituitary down-regulation (cetrorelix), ovulation induction (choriongonadotropin), and luteal phase support (intravaginal progesterone) are administered the same way in both treatment arms. |
| |