hCG Priming in Women With Diminished Ovarian Reserve

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorKristine Loessl

About this trial

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.

Eligibility criteria

Qualifiers

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)

Disqualifiers

Uterine malformations or hydrosalpinx

Submucosal uterine myomas

Uterine polyps

Allergy to standard IVF/ICSI medication

Trial design

Treatments tested in this trial

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

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Kristine Loessl

Lead sponsor

Rigshospitalet, Denmark

Sponsor institution

Copenhagen University Hospital, Hvidovre

Collaborator

Copenhagen University Hospital at Herlev

Collaborator

Odense University Hospital

Collaborator