hCG Priming in Women With Diminished Ovarian Reserve

ConditionsInfertility, Female Ovarian Reserve In Vitro Fertilization (IVF)

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

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.

Treatment groups

80 Participants

are divided into 2 treatment groups

Group A: hCG PrimingExperimental treatment 1 intervention

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes