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Trial · Interventional

CompletedPhase 4Registry data

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

Short name PRO_NAT

NCTNCT05954962 (opens ClinicalTrials.gov in a new tab)Other idIBMR43
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
150 participants (actual)
Sponsor
Instituto Bernabeu · Other
Design
Randomized · Open label (no masking)
Countries
1 country

Spain

Start
23 Dec 2023
Primary completion
3 Apr 2025
Completion
30 Aug 2025
First posted
20 Jul 2023
Last update posted
27 Mar 2026
Conditions
IVF

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2023202420252026
  1. Ph 4

    PRO_NAT

    NCT05954962

    23 Dec 2023 to 30 Aug 2025

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Progesterone 200 MGDrug
  • Ganirelix AcetateDrug

Arms2

  • 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.

  • 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.

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. MII oocytes

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

    Registry description

    number of mature (MII) oocytes in both stimulations.

Secondary outcomes(1)

  1. Duration

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

    Registry description

    duration of ovarian stimulation under both protocols.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2021

8 results

Medroxyprogesterone acetate is a useful alternative to a gonadotropin-releasing hormone antagonist in oocyte donation: a randomized, controlled trial.

Giles et al. 2021Fertility and sterilitycited by 52

PMID 33814126DOI 10.1016/j.fertnstert.2021.02.036PUB-33814126

Full text at the publisher8 results
Publisher pageSee results (8)

Indexing hint: Randomized controlled trial · 2019

9 results

Medroxyprogesterone acetate versus ganirelix in oocyte donation: a randomized controlled trial.

Beguería et al. 2019Human reproduction (Oxford, England)cited by 80

PMID 30927417DOI 10.1093/humrep/dez034PUB-30927417

Full text at the publisher9 results
Publisher pageSee results (9)

Indexing hint: Randomized controlled trial · 1998

24 results

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.

Human reproduction (Oxford, England)cited by 158

PMID 9853849DOI 10.1093/humrep/13.11.3023PUB-09853849

Full text at the publisher24 results
Publisher pageSee results (24)

More studies

1 study on this page

PubMed tag: none · 2006

Assessment of luteinizing hormone level in the gonadotropin-releasing hormone antagonist protocol.

Griesinger et al. 2006Fertility and sterilitycited by 21

PMID 16500366DOI 10.1016/j.fertnstert.2005.08.048PUB-16500366

Full text at the publisher
Publisher page

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

  • DerivedMartinez-Moya M, Guerrero J, Girela JL, Pitas A, Bernabeu A, Bernabeu R, Castillo JC. Micronized natural progesterone (Seidigestan(R)) vs GnRH antagonists for preventing the LH surge during controlled ovarian stimulation (PRO_NAT study): study protocol of a randomized clinical trial. Front Endocrinol (Lausanne). 2024 Mar 21;15:1350154. doi: 10.3389/fendo.2024.1350154. eCollection 2024. PMID 38577571

Eligibility

Who could join, as posted.

Sex
Female
Age
from 18 Years up to 33 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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