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Effect of LH Supplementation on the Endometrial Gene Expression Profile in Poor Ovarian Responders

NCT05405686 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2024-02-28

No results posted yet for this study

Summary

This is a prospective randomized open-label cross-over study. Poor responder patients will undergo two ovarian stimulation cycles. One with recombinant follicle stimulation hormone (FSH), and an other stimulation with recombinant FSH and recombinant luteinizing hormone (LH). In both groups, a freeze-all strategy will be applied and an endometrial biopsy will be taken 7 days after final oocyte maturation trigger. Endometrial gene expression analysis will be performed on both biopsies. After completion of both treatment cycles, a frozen embryo transfer of a single embryo will be performed.

Conditions

  • Poor Response to Ovulation Induction

Interventions

DRUG

Lutropin alfa

addition of recombinant luteinizing hormone

DRUG

Follitropin alfa

recombinant follicle stimulating hormone (FSH)

DIAGNOSTIC_TEST

Endometrial biopsy

pipelle de cornier biopsy

Sponsors & Collaborators

  • Merck KGaA, Darmstadt, Germany

    collaborator INDUSTRY

  • CRG UZ Brussel

    lead OTHER

Principal Investigators

  • Christophe Blockeel · UZ Brussels

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
35 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2023-08-01
Completion
2024-08-01

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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 NCT05405686 on ClinicalTrials.gov