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PCOSNCT04297553

Fresh Versus Freeze-only After CAPA IVM on PCOS Patients

A study testing CAPA-Fresh and CAPA-Freeze-only in people with PCOS and IVM, run by Mỹ Đức Hospital at 1 site in Vietnam.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable… Read more about this study

Who is it for?
Ages 18 to 37 years, women only
Conditions the study is for
PCOS, IVM, Embryo Transfer
What is being tested?
CAPA-Fresh and CAPA-Freeze-only
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteVietnam
Study dates
6 Mar 2020to 15 Dec 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 18 to 37 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Women with high AFC (≥24 Antral Follicles in Both Ovaries), including PCOS plus PCO or high AFC
  • Having indications for ART
  • Having ≤ 2 IVM/IVF attempts
  • Permanent resident in Vietnam
  • Agree to have fresh embryos transfer or freeze-only on day 3
  • Agree to have ≤ 2 embryos transferred
  • Not participating in another IVF study at the same time

Who cannot join

  • Oocyte donation cycles
  • Pre-implantation genetic diagnosis (PGD) cycles

Trial locations and contacts

1 site in 1 country.

Vietnam1 site

  • Mỹ Đức Hospital

    Ho Chi Minh City, Tan Binh

Other trials in Vietnam

About this study

Official title: Outcomes of Fresh Transfer Versus Freeze-only After CAPA IVM on PCOS Patients

IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable pregnancy outcomes.

Read the detailed description

IVM (in vitro maturation) has been proved to be a more friendly treatment protocol for PCOS (polycystic ovary syndrome) patients compared with conventional controlled ovarian stimulation, with less complications (especially ovarian hyperstimulation syndrome), shorter treatment duration, lower cost, and acceptable pregnancy outcomes. CAPA (capacitation) IVM without hCG (human chorionic gonadotropin) priming, has routinely been used at My Duc hospital for nearly 3 years to replace hCG-IVM (with hCG priming) because of absolutely synchronized oocyte maturation stage and better embryo results and better pregnancy outcomes. However, with CAPA IVM, embryos are freezed-only and will be transferred in the next cycles. This process will increase the cost of freezing and thawing embryos, and increase the treatment duration, which complicates the IVM procedure and turns IVM into an unfriendly protocol to PCOS patients. Therefore, our group conducts this study to find out the effectiveness of fresh transfer protocol after CAPA IVM compared with freezing-only CAPA IVM protocol. The fresh transfer protocol for CAPA IVM is applied from previous hCG IVM protocol, with the use of hCG and exogenous estradiol and progesterone, but at different timings.

Being tested
CAPA-Fresh, CAPA-Freeze-only

What participants receive

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

  • CAPA-FreshProcedure or surgery

    Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Receiving hCG 5000IU x 2 (10000IU) after Oocytes retrieval. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Fresh embryos transfer will be performed on day 3 using HRT protocol with a maximum of 2 embryos transferred.

  • CAPA-Freeze-onlyProcedure or surgery

    Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred.

Study groups in NCT04297553
Study groupRoleWhat they receive
CAPA-FreshActive comparatorReceiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Receiving hCG 5000IU x 2 (10000IU) after Oocytes retrieval. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Fresh embryos transfer will be performed on day 3 using HRT protocol with a maximum of 2 embryos transferred.
Receives: Procedure: CAPA-Fresh
CAPA-Freeze-onlyActive comparatorReceiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred
Receives: Procedure: CAPA-Freeze-only

What is being measured

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

  1. Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle.

    Live birth is defined as the birth of at least one newborn after 24 weeks' gestation that exhibits any sign of life (twin will be a single count).

    For the timing of this occur, ongoing pregnancy will be used, conditional on the fact that this ongoing pregnancy results in live birth.

    Measured: At 24 weeks of gestation

Secondary outcomes (18)

  1. Positive pregnancy test

    Serum human chorionic gonadotropin level greater than 5 mIU/mL

    Measured: at 2 weeks after the embryo placement after the completion of the first transfer

  2. Clinical pregnancy

    at least one gestational sac on ultrasound at 7 weeks' gestation with the detection of heart beat activity

    Measured: 5 weeks after embryo placement after the completion of the first transfer

  3. Implantation rate

    as the number of gestational sacs per number of embryos transferred

    Measured: 3 weeks after embryo transferred after the completion of the first transfer

  4. Ongoing pregnancy

    Ongoing pregnancy is defined as pregnancy with detectable heart rate at 12 weeks' gestation or beyond, after the completion of the first transfer

    Measured: At 12 weeks' gestation

  5. Number of embryos on day 3

    Number of embryos on day 3

    Measured: 5 days after oocytes pick-up

  6. Number of good quality embryo on day 3

    good quality embryos are defined followed Istanbul consensus

    Measured: 5 days after oocytes pick-up

  7. Time from randomisation to ongoing pregnancy

    Time from randomization to ongoing pregnancy after the completion

    Measured: 12 weeks of gestation after the completion of the first transfer

  8. Time from randomisation to live birth

    Time from randomization to live birth after the completion

    Measured: At the time of delivery

  9. Ovarian hyperstimulation syndrome (OHSS)

    Routine assessments for OHSS were performed on day 3 post oocyte retrieval in both groups. At other times, OHSS was evaluated if symptoms were reported by the patient. OHSS was classified using the flow diagram developed by Humaidan and colleagues for use in clinical trial settings

    Measured: at 03 days after oocytes pick-up and 14 days after embryo transfer

  10. Ectopic pregnancy

    a pregnancy in which implantation takes place outside the uterine cavity after the completion of the first transfer

    Measured: at 12 weeks of gestation after the completion of the first transfer

  11. Miscarriage

    pregnancy loss at < 24 weeks

    Measured: at 24 weeks of gestation after the completion of the first transfer

  12. Hypertensive disorders of pregnancy

    Pregnancy-induced hypertension, pre-eclampsia and eclampsia

    Measured: at 20 weeks of gestation or beyond after the completion of the first transfer

  13. Gestational diabetes mellitus

    using a 75g oral glucose tolerance test

    Measured: at 24 weeks of gestation after the completion of the first transfer

  14. Preterm delivery

    Multiple definitions, defined as delivery at <24, <28, <32, <37 completed weeks

    Measured: at 24, 28, 32 weeks and 37 weeks of gestation after the completion of the first transfer

  15. Multiple pregnancy

    Defined as presence of more than one sac at early pregnancy ultrasound (6-8 weeks gestation)

    Measured: 5 weeks after embryo placement after the completion of the first transfer

  16. Birth weight

    Weight of singletons and twins

    Measured: at the time of delivery

  17. Congenital anomaly

    Any congenital anomaly will be included

    Measured: At birth after the completion of the first transfer

  18. Cost-effectiveness

    Including direct and indirect costs; costs related to complications treatment. Cost data will be collected for a supplementary analysis and will be reported in a separated paper.

    Measured: Two year after randomization

Timeline

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

  1. First posted5 Mar 2020
  2. Study start6 Mar 2020
  3. Primary completion18 Aug 2020
  4. Study completion15 Dec 2020

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
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04297553
Sponsor's protocol ID
CS/BVMĐPN/20/01
Status last verified
Feb 2021
First submitted
2 Mar 2020
Last updated
24 Feb 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Vuong LN, Nguyen LK, Le AH, Pham HH, Ho VN, Le HL, Pham TD, Dang VQ, Phung TH, Smitz J, Ho TM. Fresh embryo transfer versus freeze-only after in vitro maturation with a pre-maturation step in women with high antral follicle count: a randomized controlled pilot study. J Assist Reprod Genet. 2021 Jun;38(6):1293-1302. doi: 10.1007/s10815-021-02180-7. Epub 2021 Apr 6.

    PubMed 33825118

Questions about this trial

What is this clinical trial studying?

A study testing CAPA-Fresh and CAPA-Freeze-only in people with PCOS and IVM, run by Mỹ Đức Hospital at 1 site in Vietnam.

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 7 inclusion and 2 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: finished, as of the sponsor's last update on 24 Feb 2021. 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 Vietnam. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Ongoing pregnancy resulting in live birth after the first embryo transfer of the started treatment cycle. (time frame: At 24 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 NCT04297553, which also lists 1 linked publication.

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 24 Feb 2021.

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