RECRUITING Phase 3 ClinicalTrials.gov

hCG Priming in Women With Diminished Ovarian Reserve

Sponsor: Kristine Loessl • ClinicalTrials.gov ID: NCT07108621

Registry updated: 2026-09-21

Recruiting for Similar Conditions?

Sponsors are looking for patients like you. See if you qualify for compensated research studies.

Description

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.

Interventions

Choriongonadotropin alfa (hCG) (Drug)
hCG 260 IU once daily for two menstrual cycles (aproximately 8 weeks) prior til standard IVF/ICSI.
Isotonic NaCl (Placebo) (Drug)
Placebo priming (isotone NaCl) once daily for two menstrual cycles (approximately 8 weeks) prior to standard IVF/ICSI.

Eligibility criteria

Inclusion Criteria: * Age 18-40 (both inclusive) * Regular menstrual cycle (23-35 days) * 1.-5. IVF/ICSI cycle at inclusion * AMH \< 6.29 pmol/L (Elecsys® AMH assay) Exclusion Criteria: * Uterine malformations or hydrosalpinx * Submucosal uterine myomas * Uterine polyps * Allergy to standard IVF/ICSI medication * Endometriosis stage III-IV * Preimplantation genetic testing * Testicular sperm aspiration/extraction * Ovarian enlargement or cysts (other than normally occurring corpora luteae) * Gynaecological haemorrhages of unknown aetiology * Known severe comorbidity\* * i.e., Insulin dependent diabetes mellitus, non-insulin dependent diabetes mellitus, gastrointestinal, cardiovascular, thromboembolic (including active thromboembolic disorders), pulmonary, liver or kidney diseases, HIV or Hepatitis B/C, dysregulated thyroid disease, tumors of the hypothalamus or pituitary gland or ovarian, uterine, or mammary carcinoma.

Conditions

Infertility, Female Ovarian Reserve In Vitro Fertilization (IVF)

Locations

Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet — Copenhagen, Denmark

Partner with Nurenyx

Showcase your study to thousands of motivated patients matching your criteria.

Learn More

Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record

Accelerate Your Clinical Trial Recruitment