IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS

NCT03463772 | Unknown DMC

• 1 other identifier: IVM/IVF-PCOS
• Study Type: interventional
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Keywords

in vitro maturation; polycystic ovarian syndrome; oocyte

Outcome Measures

Primary Outcomes (1)

• the proportion of ongoing pregnancy leading to live birth

  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

  after 22 weeks of gestation

Secondary Outcomes (10)

• implantation

  28 days after embryo transfer

• clinical pregnancy

  7 weeks after embryo transfer

• Miscarriage

  28 weeks of gestation

• Preterm birth

  28-37 weeks of pregnancy

• Birth weight

  within 2 weeks after live birth

Study Arms (2)

standard IVF

ACTIVE COMPARATOR

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

In vitro maturation

ACTIVE COMPARATOR

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.

Drug: In vitro maturation

Interventions

standard IVF PROCEDURE

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.

standard IVF

In vitro maturation DRUG

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.

Also known as: IVM

In vitro maturation

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jie Qiao: lead

Study Sites (1)

Peking University third Hospital

Beijing, Beijing Municipality, 100191, China

Location

Related Publications (2)

• 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.

  PMID: 34849920 DERIVED

• 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.

  PMID: 32295778 DERIVED

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

In Vitro Oocyte Maturation Techniques

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Jie Qiao

  Peking University Third Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: President

Model Details: 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.

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: March 13, 2018
• Study Start: March 16, 2018
• Primary Completion: June 1, 2020
• Study Completion: October 1, 2020
• Last Updated: October 29, 2019

Record last verified: 2019-10

Locations

CN (1)