Low dose hCG before IVF in women with diminished ovarian reserve

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women with a low egg reserve (diminished ovarian reserve) who are having IVF/ICSI. They get 8 weeks of low dose hCG or placebo before a second ICSI treatment.

Age

18 to 40 years (both included)

Sex

Women only

Disease stage

Diminished ovarian reserve. Regular menstrual cycle of 23-35 days.

Earlier treatment

Must be in the 1st to 5th IVF/ICSI cycle when joining.

Biomarker or test result

AMH < 6.29 pmol/L (Elecsys® AMH assay)

Main reasons for not taking part

• Malformed womb, blocked fluid-filled tube (hydrosalpinx), fibroids inside the womb lining or womb polyps
• Endometriosis stage III-IV
• Planned genetic testing of embryos or sperm taken from the testicle
• Ovarian enlargement or cysts, or vaginal bleeding of unknown cause
• Known severe illness, such as diabetes, heart, lung, liver or kidney disease, HIV, Hepatitis B/C, or certain cancers

The registry criteria, word for word

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

• Are you between 18 and 40 years old?YesNo

What the trial wants to find out

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.

The 2 groups in the trial

• hCG PrimingTreatment being tested

  Women in the experimental group will undergo the following treatment in order: A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. Priming period: hCG priming 260 IU once daily for two menstrual cycles (approximately 8 weeks). A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.

  Treatment: Choriongonadotropin alfa (hCG)

• PlaceboPlacebo, for comparison

  Women in the placebo group will undergo the following treatment in order: A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. Priming period: Placebo (isotone NaCl) injections once daily for two menstrual cycles (approximately 8 weeks). A standard IVF/ICSI cycle (ICSI I): A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and a GnRH antagonist (Ganirelix 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a single blastocyst transfer at day 5.

  Treatment: Isotonic NaCl (Placebo)