Clinical trial NCT03463772: IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PCOS
Keywords: in vitro maturation
polycystic ovarian syndrome
oocyte
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2018-03-13
Enrollment: 350
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible patients that have provided informed consent will be randomized to either IVM or standard IVF. Randomization and allocation of patients to study groups will be performed on the day 2 or 3 of the menstrual cycle. Randomization will be centrally controlled by administrative staff in the trial center, who are not involved in the treatment procedure. When there is an eligible participant to be enrolled into the study, nurses from the specific site will log in the trial center to get allocation of patients according to a computer-generated randomization list in a 1:1 ratio, with a variable block size of 2, 4 or 8 and stratified by center.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Infertile couples scheduled for their first IVF cycle.
2. Women diagonosed with polycystic ovarian syndrome.
3. Voluntary participation and informed consent obtained.

Exclusion Criteria:

1. Couple with contraindication for IVF or ICSI.
2. Couples receiving donor sperm or donor eggs.
3. Couples with indications or have plan to receive PGD and PGS.
4. Sperm analysis diagnosed as azoospermia;
5. Either male partner or female partner with an abnormal chromosome karyotype (chromosome polymorphisms was not included).
6. Women who have undergone unilateral ovariectomy.

Primary outcomes:
measure: the proportion of ongoing pregnancy leading to live birth
timeFrame: after 22 weeks of gestation
Secondary outcomes:
measure: implantation
timeFrame: 28 days after embryo transfer
measure: clinical pregnancy
timeFrame: 7 weeks after embryo transfer
measure: Miscarriage
timeFrame: 28 weeks of gestation
measure: Preterm birth
timeFrame: 28-37 weeks of pregnancy
measure: Birth weight
timeFrame: within 2 weeks after live birth
measure: Large for gestational age
timeFrame: within 2 weeks after live birth
measure: Small for gestational age
timeFrame: within 2 weeks after live birth
measure: Congenital anomaly
timeFrame: within 2 weeks after live birth
measure: Perinatal mortality
timeFrame: within 2 weeks after live birth
measure: Moderate/severe ovarian hyperstimulation syndrome (OHSS)
timeFrame: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University third Hospital
state: Beijing
Study officials:
affiliation: Peking University Third Hospital
name: Jie Qiao
role: STUDY_DIRECTOR
References:
citation: Zheng X, Guo W, Zeng L, Zheng D, Yang S, Xu Y, Wang L, Wang R, Mol BW, Li R, Qiao J. In vitro maturation without gonadotropins versus in vitro fertilization with hyperstimulation in women with polycystic ovary syndrome: a non-inferiority randomized controlled trial. Hum Reprod. 2022 Jan 28;37(2):242-253. doi: 10.1093/humrep/deab243.
citation: Zheng X, Guo W, Zeng L, Zheng D, Yang S, Wang L, Wang R, Mol BW, Li R, Qiao J. Live birth after in vitro maturation versus standard in vitro fertilisation for women with polycystic ovary syndrome: protocol for a non-inferiority randomised clinical trial. BMJ Open. 2020 Apr 14;10(4):e035334. doi: 10.1136/bmjopen-2019-035334.