CAPA-IVM Versus STANDARD IVM

NCT03921710 | Completed

• 1 other identifier: 17-2017/QD-CGRH-NCKH&DT
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate the effectiveness and safety of CAPA-IVM versus standard IVM in women with polycystic ovarian morphology (PCOM) or polycystic ovary syndrome (PCOS) .

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

• Live birth rate

  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, i.e. ongoing pregnancy at 12 weeks will be used in calculations, conditional on the fact that this ongoing pregnancy results in live birth.

  At least 24 weeks of gestation up to the time of delivery

Secondary Outcomes (8)

• Ongoing pregnancy rate

  At a minimum of 12 weeks from the beginning of the last menstrual cycle

• Clinical pregnancy rate

  At a minimum of 12 weeks from the beginning of the last menstrual cycle

• Number of oocytes retrieved

  Maximum at 30 minutes after oocyte retrieval procedure

• Oocyte maturation rate

  After at least 30 hours of maturation culture

• Number of fertilized oocytes

  16-18 hours after intra-cytoplasmic sperm injection

Study Arms (2)

CAPA-IVM

ACTIVE COMPARATOR

Immature oocytes are culture in the new capacitation-IVM system.

Drug: CAPA-IVM

Standard-IVM

ACTIVE COMPARATOR

Immature oocytes are cultured in the standard IVM system.

Drug: Standard-IVM

Interventions

CAPA-IVM DRUG

Immature oocytes were plated into a 4-well dish (Nunc, Denmark) at 10 COCs/well using CAPA medium (Medicult IVM medium; Origio, Denmark supplemented with 1 mIU/mL rFSH, 5 ng/mL insulin, 10 nM estradiol, 10 mg/mL human serum albumin \[SAGE, Denmark\] and 25 nM CNP under oil for 24 h at 37°C, 6% carbon dioxide in air). After 24 hours, COCs were washed and transferred into IVM medium (Origio, Denmark) containing 5 ng/mL insulin, 10 nM estradiol, 100 ng/mL human recombinant amphiregulin and 100 mIU/mL rFSH, and incubated under oil for 30 h at 37°C, 6% carbon dioxide in air.

CAPA-IVM

Standard-IVM DRUG

Immature oocytes are plated into a 4-well dish at 10 COCs/well using IVM medium supplemented with 75 mIU/mL recombinant FSH (Merck, Switzerland), 100 mIU/mL hCG (MSD, USA), 0.01 mg/mL growth hormone (Merck, Switzerland) and 10 mg/mL human serum albumin (SAGE, Denmark). COCs were incubated for 30 hours at 37°C, 6% carbon dioxide in air.

Standard-IVM

Eligibility Criteria

• Age: Up to 37 Years
• Gender Eligibility Details: Wives in infertile couples
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• \< 38 years
• PCOS patients with polycystic ovarian morphology: at least 25 follicles (2-9 mm) throughout the whole ovary and/or increased ovarian volume (\>10ml) (it is sufficient that 1 ovary fits these criteria)
• No major uterine or ovarian abnormalities

You may not qualify if:

• High (\>grade 2) grade endometriosis
• Cases with extremely poor sperm (OAT) such as azoospermia or cryptozoospermia

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

My Duc Hospital

Ho Chi Minh City, 70000, Vietnam

Location

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Infertility

Study Officials

• Tuong M Ho, MD

  Hope Research Center

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Randomized Clinical Trial Patients are randomized to either CAPA-IVM or STANDARD-IVM using block randomization by an independent study coordinator using a computer-generated random list (block size 4) on the second day of their periods.

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 19, 2019
• Study Start: April 29, 2017
• Primary Completion: October 10, 2018
• Study Completion: October 10, 2018
• Last Updated: April 23, 2019

Record last verified: 2019-04

Locations

VN (1)