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

NCT05405686 | Withdrawn Phase 4 DMC

• 1 other identifier: LHinPOR
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

IVF; LH supplementation; endometrial gene expression

Outcome Measures

Primary Outcomes (1)

• endometrial gene expression

  gene expression profile of the endometrium

  7 days after finale oocyte maturation trigger

Secondary Outcomes (14)

• cumulus cell gene expression

  3-6 months

• endometrial histologic analysis based on Noyes' classification system

  3-6 months

• progesterone level at oocyte triggering

  3-6 months

• follicular fluid (FF) hormonal analysis

  3-6 months

• number of preovulatory follicles

  3-6 months

Study Arms (2)

Control arm

ACTIVE COMPARATOR

In the control group, 225 IU of recombinant FSH will be administered in a fixed antagonist protocol.

Drug: Follitropin alfa; Diagnostic Test: Endometrial biopsy

Study arm

EXPERIMENTAL

In the study group, 225 IU of recombinant FSH plus 112,5 IU of recombinant LH will be administered.

Drug: Lutropin alfa; Drug: Follitropin alfa; Diagnostic Test: Endometrial biopsy

Interventions

Lutropin alfa DRUG

addition of recombinant luteinizing hormone

Study arm

Follitropin alfa DRUG

recombinant follicle stimulating hormone (FSH)

Control arm; Study arm

Endometrial biopsy DIAGNOSTIC_TEST

pipelle de cornier biopsy

Control arm; Study arm

Eligibility Criteria

• Age: 35 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 35-40 years
• Undergoing IVF/ICSI
• BMI ≥ 19 and ≤ 30
• AMH \<1.2 ng/mL
• Previous conventional ovarian stimulation (OS) with \< 4 metaphase II (MII) oocytes
• Regular menstrual cycle (26-35 days)
• Non-smokers
• Acceptance to do 2 consecutive ovarian stimulation cycles (between 1-6 months)
• Signed informed consent

You may not qualify if:

• Endometriosis \> rAFS grade II
• Testicular sperm extraction
• Recurrent miscarriage (\>2 previous miscarriages)
• Ovarian stimulation for pre-implantation genetic testing (PGT-A/M)
• Medical/social oocyte vitrification
• In vitro maturation (IVM)
• Untreated auto-immune, endocrine or metabolic disorders
• Asherman's syndrome

Sponsors & Collaborators

• CRG UZ Brussel: lead
• Merck KGaA, Darmstadt, Germany: collaborator

MeSH Terms

Interventions

Luteinizing Hormone, beta Subunit; follitropin alfa

Intervention Hierarchy (Ancestors)

Luteinizing Hormone; Gonadotropins, Pituitary; Gonadotropins; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Christophe Blockeel

  UZ Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: prospective randomized open-label cross-over study

Study Record Dates

• First Submitted: June 1, 2022
• First Posted: June 6, 2022
• Study Start: May 1, 2023
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02