PRO_NAT: Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.
Study Details
Study Description
Brief Summary
This study aims to investigate if the use of oral micronized natural progesterone is not inferior to the use of subcutaneous antagonist in preventing LH peak in controlled ovarian stimulation.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Detailed Description
The study will aim to include 150 women (egg donors): 75 per group and the principal variable will be the number of retrieved mature (MII) oocytes. Randomized, prospective, controlled, single center, phase IV study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CONTROL GROUP The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily subcutenous injections of ganirelix ("antagonist") on day 5 or 6 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval. |
Drug: Ganirelix Acetate
The patients in the control group will administer subcutaneaous injections of ganirelix from day 5-6 of stimulation as per currently used protocol.
|
| Experimental: STUDY GROUP The patient will start to administer: (1) daily subcutaneous injections of gonadotropins on day 1 of ovarian stimulation (2) daily oral capsules of natural micronized progesterone on day 1 of ovarian stimulation. Both medication will be stopped 1-2 days before egg retrieval. |
Drug: Progesterone 200 MG
The patients in the study group will administer oral natural micronized progesterone capsules from day 1 of ovarian stimulation instead of "antagonist" (ganirelix) subcutaneaous injections from day 5-6 of stimulation.
|
Outcome Measures
Primary Outcome Measures
- MII oocytes [Egg collection day (between 8 and 14 days after starting of ovarian stimulation)]
number of mature (MII) oocytes in both stimulations.
Secondary Outcome Measures
- Duration [Egg collection day (between 8 and 14 days after starting of ovarian stimulation)]
duration of ovarian stimulation under both protocols.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Eligibility for the oocyte donation program at Instituto Bernabeu.
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Age between 18 and 33 years
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BMI >18 and <30
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Overall antral follicle count >8
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Presence of both ovaries
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Ability to participate and comply with the study protocol
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Oral and written comprehension of Spanish
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Having given written consent
Exclusion Criteria:
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Endometriosis at any stage
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Any ovarian tumor whether benign or malignant
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Concurrent participation in another study
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Malabsorptive syndromes that may alter the efficacy of Seidigestan ® such as bariatric surgery, ulcerative colitis or Crohn's disease
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Irregular periods
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Hypogonadotropic hypogonadism
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Having received in the previous two months treatment with ovulation stimulators
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Having previously participated in the present study
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Instituto Bernabeu
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- A double-blind, randomized, dose-finding study to assess the efficacy of the gonadotrophin-releasing hormone antagonist ganirelix (Org 37462) to prevent premature luteinizing hormone surges in women undergoing ovarian stimulation with recombinant follicle stimulating hormone (Puregon). The ganirelix dose-finding study group. Hum Reprod. 1998 Nov;13(11):3023-31.
- Balasch J, Creus M, Fabregues F, Carmona F, Casamitjana R, Penarrubia J, Rivera F, Vanrell JA. Hormonal profiles in successful and unsuccessful implantation in IVF-ET after combined GnRH agonist/gonadotropin treatment for superovulation and hCG luteal support. Gynecol Endocrinol. 1995 Mar;9(1):51-8. doi: 10.3109/09513599509160191.
- Begueria R, Garcia D, Vassena R, Rodriguez A. Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial. Hum Reprod. 2019 May 1;34(5):872-880. doi: 10.1093/humrep/dez034.
- Castillo JC, Haahr T, Martinez-Moya M, Humaidan P. Gonadotropin-releasing hormone agonist for ovulation trigger - OHSS prevention and use of modified luteal phase support for fresh embryo transfer. Ups J Med Sci. 2020 May;125(2):131-137. doi: 10.1080/03009734.2020.1736696. Epub 2020 May 4.
- Fauser BC, Devroey P. Why is the clinical acceptance of gonadotropin-releasing hormone antagonist cotreatment during ovarian hyperstimulation for in vitro fertilization so slow? Fertil Steril. 2005 Jun;83(6):1607-11. doi: 10.1016/j.fertnstert.2005.02.011.
- Giles J, Alama P, Gamiz P, Vidal C, Badia P, Pellicer A, Bosch E. Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial. Fertil Steril. 2021 Aug;116(2):404-412. doi: 10.1016/j.fertnstert.2021.02.036. Epub 2021 Apr 2.
- Griesinger G, Dawson A, Schultze-Mosgau A, Finas D, Diedrich K, Felberbaum R. Assessment of luteinizing hormone level in the gonadotropin-releasing hormone antagonist protocol. Fertil Steril. 2006 Mar;85(3):791-3. doi: 10.1016/j.fertnstert.2005.08.048.
- Guo YC, Chen PY, Li TT, Jia L, Sun P, Zhu WS, Deng CC, Fang C, Liang XY. Different progestin-primed ovarian stimulation protocols in infertile women undergoing in vitro fertilization/intracytoplasmic sperm injection: an analysis of 1188 cycles. Arch Gynecol Obstet. 2019 Apr;299(4):1201-1212. doi: 10.1007/s00404-019-05065-4. Epub 2019 Mar 9.
- Kuang Y, Chen Q, Fu Y, Wang Y, Hong Q, Lyu Q, Ai A, Shoham Z. Medroxyprogesterone acetate is an effective oral alternative for preventing premature luteinizing hormone surges in women undergoing controlled ovarian hyperstimulation for in vitro fertilization. Fertil Steril. 2015 Jul;104(1):62-70.e3. doi: 10.1016/j.fertnstert.2015.03.022. Epub 2015 May 5.
- Macklon NS, Stouffer RL, Giudice LC, Fauser BC. The science behind 25 years of ovarian stimulation for in vitro fertilization. Endocr Rev. 2006 Apr;27(2):170-207. doi: 10.1210/er.2005-0015. Epub 2006 Jan 24.
- Messinis IE, Templeton AA. Endocrine and follicle characteristics of cycles with and without endogenous luteinizing hormone surges during superovulation induction with pulsatile follicle-stimulating hormone. Hum Reprod. 1987 Jan;2(1):11-6. doi: 10.1093/oxfordjournals.humrep.a136481.
- Porter RN, Smith W, Craft IL, Abdulwahid NA, Jacobs HS. Induction of ovulation for in-vitro fertilisation using buserelin and gonadotropins. Lancet. 1984 Dec 1;2(8414):1284-5. doi: 10.1016/s0140-6736(84)92840-x. No abstract available.
- Yu S, Long H, Chang HY, Liu Y, Gao H, Zhu J, Quan X, Lyu Q, Kuang Y, Ai A. New application of dydrogesterone as a part of a progestin-primed ovarian stimulation protocol for IVF: a randomized controlled trial including 516 first IVF/ICSI cycles. Hum Reprod. 2018 Feb 1;33(2):229-237. doi: 10.1093/humrep/dex367.
- Zhu X, Ye H, Fu Y. Duphaston and human menopausal gonadotropin protocol in normally ovulatory women undergoing controlled ovarian hyperstimulation during in vitro fertilization/intracytoplasmic sperm injection treatments in combination with embryo cryopreservation. Fertil Steril. 2017 Sep;108(3):505-512.e2. doi: 10.1016/j.fertnstert.2017.06.017. Epub 2017 Jul 8.
- IBMR43