Study of G-CSF for DOR in Patients Undergoing IVF
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age35-44
SponsorCenter for Human Reproduction
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Infertile women aged 35-44 years who have indication to undergo IVF and meet the POSEIDON group 4 (DOR): FSH <10 IU/L and AMH >1.2 ng/mL
Participants will be recruited from patients undergoing IVF treatment at The CHR
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Neupogen 300 μg subcutaneous injection
DrugParticipants 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.
Subcutaneous injections of a saline solution
Other interventionParticipants 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: G-CSF groupActive comparator 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Number of total and mature eggs retrieved
The total and mature oocyte yield resulting from ovarian stimulation cycles will be analyzed using a t-Student test, comparing the G-CSF vs. placebo groups. Binary logistic regression will be used to compare the odds of obtaining mature eggs between study groups adjusted for adjusting for age, AMH, BMI, and other baseline variables if considered appropriate.
Time frame
10-day-courseSecondary outcomes
1
Maturation, fertilization, number of viable day 3 or day 5 high quality embryos, chemical and clinical pregnancies
Number of viable day 3 or day 5 high quality embryos and clinical pregnancies will be compared using ANOVA.
Time frame
10-day-courseSponsors and contacts
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Source ClinicalTrials.gov