IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS

Not Applicable

• Conditions: PCOS
• Interventions: Procedure: standard IVF; Drug: In vitro maturation

• Registration Number: NCT03463772
• Lead Sponsor: Jie Qiao

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.

Study Timeline

• Study First Submitted: 2018-01-29
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-13
• Study Start: 2018-03-16
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-29
• Primary Completion: 2020-06
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard IVF	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.
In vitro maturation	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.

Primary Outcome Measures

Name	Time	Method
the proportion of ongoing pregnancy leading to live birth	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 Outcome Measures

Name	Time	Method
Miscarriage	28 weeks of gestation	Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age
Preterm birth	28-37 weeks of pregnancy	Birth of a fetus delieved after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy
Birth weight	within 2 weeks after live birth	Including low birth weight (defined as weight \<2500 gm at birth), very low birth weight (defined as \< 1500 gm at birth), high birth weight (defined as \> 4000 gm at birth) and very high birth weight (defined as \> 4500 gm at birth).
Moderate/severe ovarian hyperstimulation syndrome (OHSS)	From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.	exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations. It is classified as mild, moderate, or severe according to the degree of abdominal distention, ovarian enlargement and respiratory hemodynamic, and metabolic complications. Diagosised by ultrasound, blood testing and physical examination according the Chinese Medical Guildline.
implantation	28 days after embryo transfer	Number of gestational sacs observed per embryo transferred
Small for gestational age	within 2 weeks after live birth	Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.
Congenital anomaly	within 2 weeks after live birth	Any congenital anomaly will be included diagnosed by physical examinition, ultrasound or necessary testing (including CT, X-ray etc.)
Perinatal mortality	within 2 weeks after live birth	Fetal or neonatal death occurring during late pregnancy (at 28 completed weeks of gestational age and later), during childbirth, or up to seven completed days after birth.
clinical pregnancy	7 weeks after embryo transfer	one or more observed gestational sac or definitive clinical signs of pregnancy under ultrasonography at 7 weeks after embryo transfer (including clinical documented ectopic pregnancy)
Large for gestational age	within 2 weeks after live birth	Birth weight \>90th centile for gestation, based on standardised ethnicity based charts.

Trial Locations

Locations (1)

Peking University third Hospital; 🇨🇳 Beijing, Beijing, China