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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000105-23 | EudraCT Number |
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| Name | Class |
|---|---|
| Universitätsklinikum Hamburg-Eppendorf | OTHER |
| Abbott | INDUSTRY |
| KU Leuven | OTHER |
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Female inability to conceive a child. The purpose of this prospective randomized, double-blinded, double dummy, two-arm cross-over study is to investigate the difference on histological, transcriptional and immunological level in endometrium between 3x10mg Dydrogesterone oral tablets and 3x200 mg Micronized progesterone intravaginal capsules for the luteal support in egg cell donors. Beside that, the pharmacokinetics, the impact on the peripheral immunology (by blood sampling) and the microbiota (by genital swabs) will be investigated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group l: 1st cycle MVP/placebo OD | Other | 2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle.
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| Group ll: 1st cycle placebo MVP/OD | Other | 2 cycles of controlled ovarian stimulation, dual triggering, oocyte retrieval (OR) and LPS, with an interval period of 2 to 12 months. The only difference of the second cycle being the other LPS study medication as compared to the first cycle.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dydrogesterone Oral Tablet | Drug | Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days |
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| Measure | Description | Time Frame |
|---|---|---|
| Molecular endometrial level using illumina RNA-seq | To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using Illumina RNA-seq on endometrial derived single cell suspensions | On the eight day (at 8am) of LPS intake |
| Molecular endometrial level using immunohistochemistry | To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using immunohistochemistry on endometrial derived single cell suspensions | On the eight day (at 8am) of LPS intake |
| Molecular endometrial level using flow cytometry | To study the difference of OD versus MVP as LPS after controlled ovarian stimulation (COS) on the molecular endometrial level using flow cytometry on endometrial derived single cell suspensions | On the eight day (at 8am) of LPS intake |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in pharmacokinetic profile: Progesterone: AUC0-τ | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Herman Tournaye, PhD, MD | Head of department CRG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centrum voor Reproductieve Geneeskunde | Jette | Brussels Capital | 1090 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28333318 | Background | Tournaye H, Sukhikh GT, Kahler E, Griesinger G. A Phase III randomized controlled trial comparing the efficacy, safety and tolerability of oral dydrogesterone versus micronized vaginal progesterone for luteal support in in vitro fertilization. Hum Reprod. 2017 May 1;32(5):1019-1027. doi: 10.1093/humrep/dex023. |
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A randomised, cross-over, double blind double dummy study
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Blinded and packaged medication will be provided to the investigational site and dispensed to the participants. The participants, their treating physicians and the investigators will be blinded for the randomization of subjects to the treatment groups. Of both treatment medications, OD and MVP, a placebo version will be available and administered in both oocyte donation cycles. The medication will be given in a double blind double dummy fashion. All the tablets and capsules will be identical in appearance, shape, smell and taste, and packaged in the proper proportion to assure desired dosages and maintenance of the blinding.
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| Micronized progesterone | Drug | Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days |
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| Placebo Dydrogesterone oral tablet | Drug | Tablet, indistinguishable from dydrogesterone oral tablet |
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| Placebo Micronized progesterone | Drug | Capsule, indistinguishable from micronized vaginal progesterone capsules |
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| Difference in pharmacokinetic profile: Progesterone: AUC0-t |
using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) |
| On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. |
| Difference in pharmacokinetic profile: Progesterone: Cmax | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Progesterone: tmax | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Progesterone: Ctrough | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose. |
| Difference in pharmacokinetic profile: Progesterone: λz | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Progesterone: t1/2 | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Progesterone: CL/F | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Progesterone: Vz/F | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-τ | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-τ of dydrogesterone and DHD | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: AUC0-t | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of AUC0-t of dydrogesterone and DHD | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Cmax | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: ratios of Cmax of dydrogesterone and DHD | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: tmax | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the first and eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Ctrough | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: λz | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: t1/2 | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: CL/F | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in pharmacokinetic profile: Dydrogesterone and 20α-dihydrodydrogesterone: Vz/F | using Liquid Chromatography with tandem Mass Spectrometry (LC-MS/MS) | On the eight day of LPS intake: 1 hour before morning dose, 0.5 hour, 1 hour, 1 hour 30, 2 hours, 2 hours 30, 3 hours, 4 hours, 5 hours post-dose. One blood sample on the 9th, 10th and 11th day. |
| Difference in peripheral immunology | To study the effects of OD versus MVP on the peripheral immunology (using flow cytometry to investigate T regulatory and T effector cells derived from peripheral blood) | On the first and eight day of LPS intake, 1hour before morning dose at 9 am. |
| Difference in microbiota in the female genital tract | by cervical swab, a vaginal swab (posterior fornix) and an intra-uterine sample using an empty embryo catheter. Evaluation using 16S rRNA amplicon sequencing - Illumina miSeq | On the first and eight day of LPS intake, 1 hour before morning dose at 9 am. |
| ID | Term |
|---|---|
| D007247 | Infertility, Female |
| D007246 | Infertility |
| D005832 | Genital Diseases, Male |
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D004394 | Dydrogesterone |
| D011374 | Progesterone |
| C000624167 | Utrogestan |
| ID | Term |
|---|---|
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
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