Current partner codePEPTIDESDE
NCT05954962·Phase 4·INTERVENTIONAL

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

Status

Completed

Phase

Phase 4

Enrollment

150

Locations

1

Results

Not posted

Publications

12

Study summary

What the protocol is testing.

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.

Full 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.

Interventions

Treatment arms and agents.

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.

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.

Timeline

From registration to results.

  1. First posted

    Jul 20, 2023

  2. Study start

    Dec 23, 2023

  3. Primary completion

    Apr 3, 2025

  4. Study completion

    Aug 30, 2025

  5. Results posted

    Not reported

  6. Registry updated

    Mar 27, 2026

Outcomes

What the study measures.

Primary outcomes

MII oocytes

Time frame · Egg collection day (between 8 and 14 days after starting of ovarian stimulation)

number of mature (MII) oocytes in both stimulations.

Secondary outcomes

Duration

Time frame · Egg collection day (between 8 and 14 days after starting of ovarian stimulation)

duration of ovarian stimulation under both protocols.

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
33 Years
Sex
FEMALE
Healthy volunteers
Yes

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

Study locations

1 registered sites.

Spain. Showing up to 24 locations stored in the fast local snapshot.

Instituto Bernabeu

Elche, Alicante, Spain

Publications

Results and literature.

PMID 9853849A 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.PMID 7793300Balasch 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.PMID 30927417Begueria 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.PMID 32366146Castillo 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.PMID 15950626Fauser 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.PMID 33814126Giles 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.PMID 16500366Griesinger 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.PMID 30852654Guo 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.PMID 25956370Kuang 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.PMID 16434510Macklon 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.PMID 3106404Messinis 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.PMID 6150318Porter 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.

Primary links

Continue at the source.

Related trials

More studies on Ganirelix.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.