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IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS

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ClinicalTrials.gov Identifier: NCT03463772
Recruitment Status : Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Jie Qiao, Peking University Third Hospital

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.

Condition or disease Intervention/treatment Phase
PCOS Procedure: standard IVF Procedure: In vitro maturation Not Applicable

Detailed Description:
A single center, randomized controlled clinical trial will enroll 820 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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : April 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: 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.
Procedure: standard IVF
Ovarian stimulation will be performed by a standard protocol using gonadotrophin-releasing hormone antagonist (GnRH-ant) in association with recombinant FSH (rFSH) and human chorionic gonadotrophin (hCG).Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be inseminated using ICSI or conventional IVF according to the seman analysis. All embryos will be cultured to blastocyst stage and be vitrified.

Active Comparator: 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.
Procedure: In vitro maturation
Controlled ovarian stimulation protocol will not performed in this group patients. Transvaginal ultrasound scanning was examined on natural cycle to monitor the follicle size in group B participants. Oocyte retrieval was scheduled once the endometrium had reached at least 6 mm in thickness and there was no follicle larger than 10 mm. After oocyte retrieval, the COCs will be cultured for 28-32h in special IVM media in order to get the matured oocytes. All the metaphase II (MII) oocytes were inseminated by means of intracytoplasmic sperm injection (ICSI). All embryos will be cultured to blastocyst stage and be vitrified.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. implantation [ Time Frame: 28 days after embryo transfer ]
    Number of gestational sacs observed per embryo transferred

  2. clinical pregnancy [ Time Frame: 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)

  3. Miscarriage [ Time Frame: 28 weeks of gestation ]
    Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age

  4. Preterm birth [ Time Frame: 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

  5. Birth weight [ Time Frame: 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).

  6. Large for gestational age [ Time Frame: within 2 weeks after live birth ]
    Birth weight >90th centile for gestation, based on standardised ethnicity based charts.

  7. Small for gestational age [ Time Frame: within 2 weeks after live birth ]
    Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.

  8. Congenital anomaly [ Time Frame: 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.)

  9. Perinatal mortality [ Time Frame: 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.

  10. Moderate/severe ovarian hyperstimulation syndrome (OHSS) [ Time Frame: 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.



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Ages Eligible for Study:   20 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463772


Contacts
Contact: Xiaoying Zheng 86-10-82265033 zheng_xiaoying@126.com
Contact: Rui Yang 86-10-82265080 yrjeff@126.com

Locations
China, Beijing
Peking University third Hospital
Beijing, Beijing, China, 100191
Sponsors and Collaborators
Jie Qiao
Investigators
Study Director: Jie Qiao Peking University Third Hospital

Responsible Party: Jie Qiao, President, Peking University Third Hospital
ClinicalTrials.gov Identifier: NCT03463772     History of Changes
Other Study ID Numbers: IVM/IVF-PCOS
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jie Qiao, Peking University Third Hospital:
in vitro maturation
polycystic ovarian syndrome
oocyte