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Luteal Phase Ovarian Stimulation With Follitropin Delta and Dydrogesterone

NCT05521828 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-08

No results posted yet for this study

Summary

The last decade has shown a progressive scientific interest for new strategies to improve the outcomes of controlled ovarian stimulation (COS).

Given the fact that interovulatory period has been described to have multiple waves of follicular recruitment, luteal phase ovarian stimulation (LPOS) has been proposed as new protocol for COS, with satisfactory ovarian response and pregnancy outcomes. On the other hand progestin-primed ovarian stimulation (PPOS) is today considered an innovative protocol aiming to achieve multi-follicle recruitment and block the luteinizing hormone (LH) surge through progesterone administration in place of the traditional down regulating or gonadotropin-releasing hormone (GnRH) antagonist. This protocol has been shown to be equally effective as LH suppression with GnRH antagonist reporting equivalent oocyte retrieval rates, endocrine profiles, viable embryo numbers, and pregnancy outcomes. Due to the feasibility and patients-friendly characteristics of PPOS in oocytes donors, the current study aims to investigate the impact on the number of cumulus-oocyte complexes (COCs) when a PPOS protocol is associated to both conventional follicular phase stimulation and LPOS for vitrification of oocytes in oocyte donors. Moreover, it aims to determine whether LPOS using PPOS protocol has comparable outcomes to conventional follicular phase stimulation with PPOS protocol, in oocyte donor patients.

Conditions

  • Oocyte Donors
  • Oocyte Donation

Interventions

DRUG

Follitropin delta (Rekovelle)

12 mcg/day will be used for ovarian stimulation in both arms

DRUG

Duphaston

20 mg/day will be used for pituitary suppression in both arms

DRUG

GnRH agonist (Gonapeptyl)

(2 ampules:0.2 mg) will be used for ovulation triggering in both arms

Sponsors & Collaborators

  • CRG UZ Brussel

    lead OTHER

Principal Investigators

  • Christophe Blockeel, Prof, MD · Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel, Belgium

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
36 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-01
Primary Completion
2024-09-30
Completion
2024-12-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05521828 on ClinicalTrials.gov