In Vitro Maturation Versus Standard in Vitro Fertilization in Infertile Patients Diagnosed With Polycystic Ovaries Syndrome: a Study Protocol for a Single-center Prospective, Randomized Controlled Clinical Trial
Overview
- Phase
- Not Applicable
- Intervention
- standard IVF
- Conditions
- PCOS
- Sponsor
- Jie Qiao
- Enrollment
- 350
- Locations
- 1
- Primary Endpoint
- the proportion of ongoing pregnancy leading to live birth
- Last Updated
- 6 years ago
Overview
Brief Summary
A single center, prospective, open-label, non-inferiority randomized controlled clinical trials (1:1 treatment ratio) regarding pregnancy outcomes between IVM and standard IVF among infertility couples with PCOS in China.
Detailed Description
A single center, randomized controlled clinical trial will enroll 350 couples with PCOS undergoing their first cycle of IVF. The participation in this study will be approximately 2 years with a total of 7 visits from the cycle beginning, pregnancy to delivery. On day 2 or day 3 following the onset of menstrual bleeding, eligible patients will be allocated to two groups at a ratio of 1:1- IVM protocol, and standard IVF protocol. All participants will be randomized through stratified block randomization according to the study sites.
Investigators
Jie Qiao
President
Peking University Third Hospital
Eligibility Criteria
Inclusion Criteria
- •Infertile couples scheduled for their first IVF cycle.
- •Women diagonosed with polycystic ovarian syndrome.
- •Voluntary participation and informed consent obtained.
Exclusion Criteria
- •Couple with contraindication for IVF or ICSI.
- •Couples receiving donor sperm or donor eggs.
- •Couples with indications or have plan to receive PGD and PGS.
- •Sperm analysis diagnosed as azoospermia;
- •Either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included).
- •Women who have undergone unilateral ovariectomy.
Arms & Interventions
standard IVF
On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group A will receive standard IVF procedure. Other standard assisted reproductive treatments are similar and parallel between two groups.
Intervention: standard IVF
In vitro maturation
On the Day2/3 of the menstrual cycle, qualified participants will be randomized into either of two groups. Participants in group B will receive IVM procedure.Other standard assisted reproductive treatments are similar and parallel between two groups.
Intervention: In vitro maturation
Outcomes
Primary Outcomes
the proportion of ongoing pregnancy leading to live birth
Time Frame: after 22 weeks of gestation
number of ongoing pregnancy leading to live birth resulting from the first oocyte retrieval cycle after the randomization ( 6 month) divided by the number of patients with oocyte retrieval
Secondary Outcomes
- Miscarriage(28 weeks of gestation)
- Preterm birth(28-37 weeks of pregnancy)
- Birth weight(within 2 weeks after live birth)
- Moderate/severe ovarian hyperstimulation syndrome (OHSS)(From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.)
- implantation(28 days after embryo transfer)
- Small for gestational age(within 2 weeks after live birth)
- Congenital anomaly(within 2 weeks after live birth)
- Perinatal mortality(within 2 weeks after live birth)
- clinical pregnancy(7 weeks after embryo transfer)
- Large for gestational age(within 2 weeks after live birth)