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PCOSNCT03463772

IVM Versus Standard IVF in Infertile Patients Diagnosed With PCOS

A study testing standard IVF and In vitro maturation in people with PCOS, run by Jie Qiao at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 38 years, women only
Conditions the study is for
PCOS
What is being tested?
standard IVF and In vitro maturation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
1 siteChina
Study dates
16 Mar 2018to Oct 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 38 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Peking University third Hospital

    Beijing, Beijing Municipality, 100191

Other trials in China

About this study

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

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.

Read the 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.

Conditions
PCOS
Being tested
standard IVF, In vitro maturation
Keywords
in vitro maturation, polycystic ovarian syndrome, oocyte
Medical subject headings
Polycystic Ovary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • standard IVFProcedure or surgery

    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 maturationDrug

    Also called IVM

    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.

Study groups in NCT03463772
Study groupRoleWhat they receive
standard IVFActive comparatorOn 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.
Receives: Procedure: standard IVF
In vitro maturationActive comparatorOn 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.
Receives: Drug: In vitro maturation

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: after 22 weeks of gestation

Secondary outcomes (10)

  1. implantation

    Number of gestational sacs observed per embryo transferred

    Measured: 28 days after embryo transfer

  2. clinical pregnancy

    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)

    Measured: 7 weeks after embryo transfer

  3. Miscarriage

    Spontaneous loss of an intra-uterine pregnancy prior to 28 completed weeks of gestational age

    Measured: 28 weeks of gestation

  4. Preterm birth

    Birth of a fetus delieved after 28 and before 37 completed weeks of gestational age in participants confirmed ongoing pregnancy

    Measured: 28-37 weeks of pregnancy

  5. Birth weight

    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).

    Measured: within 2 weeks after live birth

  6. Large for gestational age

    Birth weight >90th centile for gestation, based on standardised ethnicity based charts.

    Measured: within 2 weeks after live birth

  7. Small for gestational age

    Less than 10th centile for gestational age at delivery based on standardised ethnicity based charts.

    Measured: within 2 weeks after live birth

  8. Congenital anomaly

    Any congenital anomaly will be included diagnosed by physical examinition, ultrasound or necessary testing (including CT, X-ray etc.)

    Measured: within 2 weeks after live birth

  9. Perinatal mortality

    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.

    Measured: within 2 weeks after live birth

  10. Moderate/severe ovarian hyperstimulation syndrome (OHSS)

    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.

    Measured: From date of controlled ovarian hyperstimulation until the date of oocyte retrieval, assesses about 14-16 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Mar 2018
  2. Study start16 Mar 2018
  3. Primary completionJun 2020 (estimated)
  4. Study completionOct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
350 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03463772
Sponsor's protocol ID
IVM/IVF-PCOS
Status last verified
Oct 2019
First submitted
29 Jan 2018
Last updated
29 Oct 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Guo W, Yang Y, Qin M, Kong S, Wang L, Zheng X, Yang R, Yang S, Zhen X, Zhu X, Li R, Yan L, Qiao J, Yan Z. Epigenetic safety of in vitro maturation in PCOS: genome-wide DNA methylation profiling of cord blood from a randomized controlled trial. J Ovarian Res. 2026 Jun 27. doi: 10.1186/s13048-026-02179-7. Online ahead of print.

    PubMed 42365361

  • 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.

    PubMed 34849920

  • 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.

    PubMed 32295778

Questions about this trial

What is this clinical trial studying?

A study testing standard IVF and In vitro maturation in people with PCOS, run by Jie Qiao at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the proportion of ongoing pregnancy leading to live birth (time frame: after 22 weeks of gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03463772, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2019.

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