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Completed

NCT Number: NCT04297553

Fresh 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.

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Key information

Conditions

PCOS Embryo Transfer IVM

Age range

18 year–37 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mỹ Đức Hospital

Ho Chi Minh City, Tan Binh, Vietnam

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

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

Treatment and study plan

CAPA-Fresh

Procedure

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-only

Procedure

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.

Primary outcomes

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

    Time frame: At 24 weeks of gestation

    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.

Secondary outcomes

  1. Positive pregnancy test

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

    Serum human chorionic gonadotropin level greater than 5 mIU/mL

  2. Clinical pregnancy

    Time frame: 5 weeks after embryo placement after the completion of the first transfer

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

  3. Implantation rate

    Time frame: 3 weeks after embryo transferred after the completion of the first transfer

    as the number of gestational sacs per number of embryos transferred

  4. Ongoing pregnancy

    Time frame: At 12 weeks' gestation

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

  5. Number of embryos on day 3

    Time frame: 5 days after oocytes pick-up

    Number of embryos on day 3

  6. Number of good quality embryo on day 3

    Time frame: 5 days after oocytes pick-up

    good quality embryos are defined followed Istanbul consensus

  7. Time from randomisation to ongoing pregnancy

    Time frame: 12 weeks of gestation after the completion of the first transfer

    Time from randomization to ongoing pregnancy after the completion

  8. Time from randomisation to live birth

    Time frame: At the time of delivery

    Time from randomization to live birth after the completion

  9. Ovarian hyperstimulation syndrome (OHSS)

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

    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

  10. Ectopic pregnancy

    Time frame: at 12 weeks of gestation after the completion of the first transfer

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

  11. Miscarriage

    Time frame: at 24 weeks of gestation after the completion of the first transfer

    pregnancy loss at < 24 weeks

  12. Hypertensive disorders of pregnancy

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

    Pregnancy-induced hypertension, pre-eclampsia and eclampsia

  13. Gestational diabetes mellitus

    Time frame: at 24 weeks of gestation after the completion of the first transfer

    using a 75g oral glucose tolerance test

  14. Preterm delivery

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

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

  15. Multiple pregnancy

    Time frame: 5 weeks after embryo placement after the completion of the first transfer

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

  16. Birth weight

    Time frame: at the time of delivery

    Weight of singletons and twins

  17. Congenital anomaly

    Time frame: At birth after the completion of the first transfer

    Any congenital anomaly will be included

  18. Cost-effectiveness

    Time frame: Two year after randomization

    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.

Sponsors and collaborators

Lead sponsor

Mỹ Đức Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 5, 2020
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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