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hCG Priming in Women With Diminished Ovarian Reserve

RecruitingPhase 3Ages 18 Years - 40 YearsFemaleKristine Loessl
NCT07108621 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Choriongonadotropin alfa (hCG)
  • Isotonic NaCl (Placebo)
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Where

1 site
Fertility Clinic, Department of Gynaecology, Fertility and Obstetrics, Copenhagen University Hosital Rigshospitalet
Copenhagen, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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