Research Protocol for a Double-Blinded Randomized Trial of Granulocyte Colony Stimulating Factor (G-CSF) for Treatment of Diminished Ovarian Reserve in Patients Undergoing In Vitro Fertilization (IVF)

Summary

Diminished ovarian reserve (DOR) is defined by reduced follicle counts in women, associated with decreased fertility and lower success rates with In Vitro Fertilization (IVF). Granulocyte Colony Stimulating Factor (G-CSF) is a medication that has been proposed as a potential treatment for DOR, as it may help to improve ovarian function and increase the number of mature eggs available for fertilization. However, the efficacy and safety of G-CSF for DOR in IVF patients have not been definitively established. Therefore, our research protocol aims to assess the effectiveness of G-CSF in improving IVF outcomes in patients with DOR in POSEIDON group 4 (age ≥35 years and AMH \<1.2 ng/mL). In this double-blinded randomized controlled trial, 140 participants with DOR will receive subcutaneously 5 single doses of 300 μg of G-CSF (Neupogen, study group) or saline solution (placebo, control group), administered as one injection every other day starting in early luteal phase and for a total of 10 days, during standard IVF priming. All participants will undergo ovarian stimulation for IVF in the subsequent menstrual cycle following CHR's clinical protocols. The primary outcomes will be the total number of eggs and of mature eggs retrieved. Secondary outcomes will include maturation, fertilization, viable day 3 or day 5 high quality embryos and clinical pregnancies, as well as collecting safety data. Findings of this study may help to clarify the effect of G-CSF on ovarian function and IVF outcomes in women with DOR.

Eligibility

Age range

35–44 years

Sex

Female

Healthy volunteers

No

Interventions

• Drug
  Neupogen 300 μg subcutaneous injection

  Participants in the G-CSF group will receive a Neupogen 300 μg subcutaneous injection every other day, starting in early luteal phase and until completing 5 doses (10-day-course). Both the G-CSF group and the placebo group will initiate standard controlled ovarian stimulation (COS) with gonadotropins within the following menstrual cycle according to the clinic's protocols.

• Other
  Subcutaneous injections of a saline solution

  Participants in the placebo group will receive subcutaneous injections of a saline solution instead, following the same schedule. Both the G-CSF group and the placebo group will initiate standard controlled ovarian stimulation (COS) with gonadotropins within the following menstrual cycle according to the clinic's protocols.

Location