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OpenTrials
Completed

NCT Number: NCT05954962

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

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.

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Key information

Conditions

IVF

Age range

18 year–33 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Instituto Bernabeu

Elche, Alicante, 03206, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone 200 mg

Drug

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

Drug

The patients in the control group will administer subcutaneaous injections of ganirelix from day 5-6 of stimulation as per currently used protocol.

Primary outcomes

  1. 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

  1. Duration

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

    duration of ovarian stimulation under both protocols.

Sponsors and collaborators

Lead sponsor

Instituto Bernabeu

Other

Registry information

Official study 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.

Acronym: PRO_NAT

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2023
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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