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hCG Priming in Women With Diminished Ovarian Reserve

NCT07108621 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-09-17

No results posted yet for this study

Summary

The aim of this randomized controlled trial is to further examine the possible effects of low dose human chorionic gonadotropin (hCG) priming for eight weeks in women with diminished ovarian reserve (DOR) undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). The investigators want to retest the findings of our first study in an identical paired design (NCT04643925), as an increase of 1.5 in mean number of oocytes retrieved is clinically relevant. To incorporate the strengths of a randomized controlled trial design, women will be randomized after their first ICSI treatment to receive either hCG or placebo in a double-blinded design during an eight-week priming period preceding their second ICSI treatment. The primary outcome is the number of oocytes retrieved in the second ICSI treatment.

Conditions

  • Infertility, Female
  • Ovarian Reserve
  • In Vitro Fertilization (IVF)

Interventions

DRUG

Choriongonadotropin alfa (hCG)

hCG 260 IU once daily for two menstrual cycles (aproximately 8 weeks) prior til standard IVF/ICSI.

DRUG

Isotonic NaCl (Placebo)

Placebo priming (isotone NaCl) once daily for two menstrual cycles (approximately 8 weeks) prior to standard IVF/ICSI.

Sponsors & Collaborators

  • Copenhagen University Hospital, Hvidovre

    collaborator OTHER

  • Copenhagen University Hospital at Herlev

    collaborator OTHER

  • Odense University Hospital

    collaborator OTHER

  • Kristine Loessl

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-09-30
Primary Completion
2028-03-31
Completion
2031-03-31

Countries

  • Denmark

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 NCT07108621 on ClinicalTrials.gov