Efficacy of Micronized Natural Progesterone vs GnRH Antagonist in the Prevention of LH Peak During Ovarian Stimulation.

IVF Clinical Trial

— PRO_NAT  

Official title:

Evaluation of the Efficacy of Micronized Natural Progesterone (Seidigestan®) vs GnRH Antagonist (Astarté®) in the Prevention of LH Peak During Controlled Ovarian Stimulation: a Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05954962
• Other study ID #: IBMR43
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 23, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: September 2023
• Source: Instituto Bernabeu
• Contact: Anna Pitas, PhD
• Phone: +34663926079
• Email: apitas[@]institutobernabeu.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: September 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 33 Years

Eligibility

Inclusion Criteria:

• Eligibility for the oocyte donation program at Instituto Bernabeu.

• Age between 18 and 33 years

• BMI >18 and <30

• Overall antral follicle count >8

• Presence of both ovaries

• Ability to participate and comply with the study protocol

• Oral and written comprehension of Spanish

• Having given written consent

Exclusion Criteria:

• Endometriosis at any stage

• Any ovarian tumor whether benign or malignant

• Concurrent participation in another study

• Malabsorptive syndromes that may alter the efficacy of Seidigestan ® such as bariatric surgery, ulcerative colitis or Crohn's disease

• Irregular periods

• Hypogonadotropic hypogonadism

• Having received in the previous two months treatment with ovulation stimulators

• Having previously participated in the present study

Related Conditions & MeSH terms

• IVF

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Bernabeu

References & Publications (14)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MII oocytes	number of mature (MII) oocytes in both stimulations.	Egg collection day (between 8 and 14 days after starting of ovarian stimulation)
Secondary	Duration	duration of ovarian stimulation under both protocols.	Egg collection day (between 8 and 14 days after starting of ovarian stimulation)