Study of Super-GDF9 Addition to Improve In Vitro Maturation of Human Oocytes from Small Antral Follicles Using CAPA-IVM Technique
Led by Mỹ Đức Hospital · Updated on 2025-07-10
9
Participants Needed
1
Research Sites
62 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are investigating the use of CAPA-IVM In Vitro Maturation technology, an assisted reproductive method that offers advantages in safety and treatment cost, especially for women at high risk such as those with ovarian hyperstimulation syndrome, venous thrombosis, ovarian torsion, or polycystic ovary syndrome PCOS. While CAPA-IVM shows a live birth rate comparable to conventional IVF, the number of good-quality embryos and overall pregnancy rates are lower. This trial aims to improve CAPA-IVM outcomes by supplementing the culture with super GDF9, a potent growth factor that supports follicular development and oocyte quality.
The study compares two groups of cumulus-oocyte complexes COCs collected from small follicles during oocyte pick-up procedures. One group will receive CAPA-IVM culture with added super GDF9 at 50 ngml during both capacitation and maturation steps, while the control group will undergo the same CAPA-IVM process without super GDF9. Fertilization will be performed by intracytoplasmic sperm injection ICSI, and samples such as spent media and cumulus cells will be collected for analysis.
Participants will undergo screening and consent before oocyte retrieval, with follow-up assessments at specific time points after fertilization to measure outcomes like maturation rates, fertilization rates, embryo quality, and gene expression. The primary outcome is the maturation rate per COC two days after retrieval. Secondary outcomes include degeneration rates, embryo development timing, blastocyst quality, and genetic evaluations extending up to about one year after study completion. The study plans to enroll around 10 patients to obtain 300 COCs for analysis.
CONDITIONS
Brief Title
Effect of Super-GDF9 on CAPA-IVM of COCs From Small Antral Follicles
Research Team
K
Kha T Huynh
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Diagnosed with polycystic ovary syndrome (PCOS) by Rotterdam criteria (2003)
Indicated for CAPA-IVM treatment
Serum AMH level of 4 ng/mL or higher at screening and at least 24 antral follicles in both ovaries by ultrasound
Willing to donate cumulus-oocyte complexes (COCs) for research
Agree to frozen embryo
Signed informed consent before any study procedures
You will not qualify if you...
Known endometrioma or severe (grade 3-4) endometriosis
Uterine abnormalities
Couples with severe male factor infertility (sperm concentration less than 5 million/ml, motility less than 10%) or requiring surgical sperm retrieval
Previous history of unexplained immature oocytes after IVF treatment
Cycles using donor oocytes
Your Study Journey
Screening
Duration - 1 to 7 days
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Oocyte Retrieval and CAPA-IVM Culture
Duration - 2 days after oocyte retrieval
Participants undergo oocyte retrieval. Donated cumulus-oocyte complexes (COCs) from small follicles are cultured in the CAPA and IVM steps, either with the addition of Super-GDF9 or without it, according to group assignment.
1 procedure visit and 1 culture period
Intracytoplasmic Sperm Injection (ICSI) and Embryo Assessment
Duration - 5 to 6 days after ICSI
Mature oocytes are fertilized using ICSI. Participants' embryos are assessed for fertilization, degeneration, and developmental milestones up to 5 to 6 days after ICSI.
1 fertilization procedure and follow-up assessments over several days
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
In vitro maturation: a committee opinion.
Practice Committees of the American Society for Reproductive Medicine, the Society of Reproductive Biologists and Technologists, and the Society for Assisted Reproductive Technology. Electronic address: jgoldstein@asrm.org
In-vitro maturation of oocytes versus conventional IVF in women with infertility and a high antral follicle count: a randomized non-inferiority controlled trial.
Effects of lactate, super-GDF9, and low oxygen tension during bi-phasic in vitro maturation on the bioenergetic profiles of mouse cumulus-oocyte complex†.
DNA methylation and mRNA expression of imprinted genes in blastocysts derived from an improved in vitro maturation method for oocytes from small antral follicles in polycystic ovary syndrome patients.