IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-16

Study Completion Date

2020-10-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

standard IVF

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

In vitro maturation

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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IVM

Eligibility Criteria

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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.

Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No