Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aims to predefine the threshold FSH doses during the early follicular phases in low- dose step-up ovulation induction cycles used to treat anticipated high responders by monitoring total testosterone and androstenedione blood levels. The blood levels of total testosterone and androstenedione levels will be measured in patients at the starting day and at every control day when vaginal sonographic folliculometries and blood estradiol measurements are made. Hence, we are aiming to define an early monitoring parameter by which we will be able to define a follicular response to treatment before estradiol rise or apparently selected follicular growth.
50 patients with anticipated high ovarian response, who are being planned to be conventionally treated with low-dose step-up ovulation induction and intrauterine insemination will be analysed in this study. At every control day including the start day, blood samples taken for blood estradiol (and if required progesterone) measurements will be used to measure blood androstenedione and total testosterone levels, as well. Hence, we will have defined an early parameter for defining follicular response in the first 5-7 days of low-dose step-up ovulation induction. Low-dose step-up ovulation induction will be started at 50-75Units/day of rhFSH and the dose will be increased at not earlier than the 7th day at an increment of +37,5Units/day unless a response is observed ( which is at least a 10mm follicle, selected for growth). If more than 3 dominant follicles are selected, the cycle will be cancelled. Otherwise, when at least one follicle >16mm is obtained, a 150Microgram sc. injection will be administered for ovulation trigger and intrauterine insemination made at the 34th-36th hours.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High responder infertile patients | Ovarian high responder patients who are being planned for low-dose step-up protocol ovulation induction and intrauterine insemination. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Blood androstenedione and testosterone levels. | Patterns of blood androstenedione and testosterone levels with respect to the regular monitoring parameters and relations to secondary outcomes. | within 10-20 days |
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy | blood hCG level >10mIU/mlt | 20-30 days |
| Cycle cancellation | cancellation of treatment despite 2 rounds of dose step-up | within 10-20 days |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Primary/Secondary Infertile patients (couples); ovarian high response to ovulation induction anticipated; with mild male factor or without any male factor. Hysterosalpingography reveals patent uterine tubes and normal uterine cavity.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eser S Ozyurek, MD | Contact | +905309322345 | eozyurek@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Eser S Ozyurek, MD | Bagcilar Training and Research Hospital | Study Director |
| Erdal Kaya, Prof Dr | Bagcilar Training and Research Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bagcilar Training and Research Hospital | Recruiting | Istanbul | 34200 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28494798 | Derived | Ozyurek ES, Yoldemir T, Artar G. Androstenedione response to recombinant human FSH is the most valid predictor of the number of selected follicles in polycystic ovarian syndrome: (a case-control study). J Ovarian Res. 2017 May 12;10(1):34. doi: 10.1186/s13048-017-0330-7. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| D016471 | Ovarian Hyperstimulation Syndrome |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| Ovarian hyperstimulation | Enlarged ovaries, abdominal ascites, pleural effusion, hemoconcentration, abdominal swelling | 10-30 days |
| Need for dose step-up | if at the 7th day of a dose, no follicle(s)>10mm are observed then the dose is increased | 7-14 days |
| Mustafa U Karacaoglu, MD |
| Bagcilar Training and Research Hospital |
| Study Chair |
| Evrim E Kovalak, MD | Bagcilar Training and Research Hospital | Study Chair |
| Erdinc Ergul, MD | Bagcilar Training and Research Hospital | Study Chair |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |