Non-FSH vs FSH-priming in Cycles With CAPA-IVM Treatment

NCT05600972 | Completed DMC

• 1 other identifier: 13/22/DD-BVMD
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

In vitro oocyte maturation (IVM) is an assisted reproductive technology requiring minimal or no ovarian stimulation. In this technique, the immature oocytes were retrieved from follicles and subsequently cultured matured, meaning that GV oocytes reached MII in vitro (ASRM, 2021). Currently, there is no consensus on the unique IVM protocol. However, recommended protocols that are being utilized include IVM with and without hCG (Standard IVM) and CAPA-IVM. As mentioned previously, FSH priming before oocyte retrieval for IVM remains controversial. However, FSH is known as a hormone for the maturation of the follicles. Therefore, during oocyte maturation (IVM) cycles, FSH is used to "prime" follicular development. Generally, many studies showed a trend of a higher number of MII oocytes obtained after IVM after using FSH priming. In animal models, Younis et al. (1994) observed a significant increase in the number of mature oocytes when performing IVM in cynomolgus monkeys (Macaca fascicularis) with a dose of 1000 IU of PMSG (pregnant mare's serum gonadotropin) in the follicular phase (Younis et al., 1994). Similarly, Wynn et al. (1998) conducted a study on mice. The results from this study revealed that a higher number of MII oocytes was observed. Still, the blastulation rate and the number of blastomeres were significantly lower than that without FSH priming. On the other hand, FSH activates meiosis resumption (Wynn et al., 1998). In addition, an RCT of 28 patients comparing three days of 150 IU of FSH before the IVM aspiration group with the control group also showed an improvement in implantation rates in IVM cycles with FSH priming (Mikkelsen et al., 2001). The studies mentioned above both used the non-hCG IVM protocol. Other studies by Shalom-Paz et al. (2011) and Choavaratana et al. (2015) showed superiority in the number of MII oocytes. There has been no data on the impact of not using FSH priming in CAPA-IVM cycles. Therefore, this RCT will investigate the efficacy of CAPA-IVM with and without FSH priming.

Conditions

in Vitro Maturation; FSH Priming

Keywords

in vitro maturation, FSH priming

Outcome Measures

Primary Outcomes (1)

• Number of matured oocytes after CAPA-IVM cultured

  Number of oocytes at MII stage after CAPA-IVM cultured

  2 day after oocyte retrieval

Secondary Outcomes (18)

• Positive pregnancy test rate

  2 weeks after embryo transfer

• Implantation rate

  3 weeks after embryo transfer

• Ectopic pregnancy rate

  4 weeks after embryo transfer

• Clinical pregnancy rate

  5 weeks after embryo transfer

• Ongoing pregnancy rate

  10 weeks after embryo transfer

Study Arms (2)

non-FSH priming

NO INTERVENTION

Routine CAPA-IVM treatment will be performed. The oocyte retrieval will be performed 2 days after the randomization accordingly to the current routine procedures. An ultrasound scan will be performed to exclude the development of any dominant follicle.

FSH priming

ACTIVE COMPARATOR

Routine CAPA-IVM treatment will be performed. Patients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection.

Procedure: FSH priming

Interventions

FSH priming PROCEDURE

Patients who are randomized into the FSH priming arm will receive two days of FSH injections of 150 IU/day. Oocyte retrieval will be scheduled at 42 hours after the last FSH injection.

FSH priming

Eligibility Criteria

• Age: 18 Years - 37 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Aging from 18 to 37
• Diagnosed with PCOS followed by Rotterdam criteria
• Having an indication for CAPA-IVM treatment
• Agree to have all embryos frozen on day 5/6.
• Agree to have one blastocyst (if of good quality defined as 3BB or above) or up to two blastocysts (if no good quality are available) transferred in a subsequent frozen transfer
• Having ≤ 2 IVM/IVF attempts

You may not qualify if:

• A previous ovarian stimulation (for OI or IVF) within the previous three months
• Cycles with oocytes donation
• Uterine or ovarian abnormalities
• Previous evidence of a very low oocyte maturation without suspicion of FSH /LH receptor defect
• Cycles with sperms retrieved after PESA/TESE/microTESE

Sponsors & Collaborators

• Mỹ Đức Hospital: lead

Study Sites (1)

IVFMD - My Duc Hospital

Ho Chi Minh City, Vietnam

Location

Related Publications (1)

• Vuong LN, Ho VNA, Le AH, Nguyen NT, Pham TD, Nguyen MHN, Le HL, Le TK, Ha AN, Le XTH, Pham HH, Tran CT, Huynh BG, Smitz JEJ, Gilchrist RB, Ho TM. Hormone-free vs. follicle-stimulating hormone-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized controlled trial. Fertil Steril. 2025 Feb;123(2):253-261. doi: 10.1016/j.fertnstert.2024.09.010. Epub 2024 Sep 12.

  PMID: 39260537 DERIVED

Study Officials

• Lan N Vuong, M.D., Ph.D.

  IVFMD and HOPE Research Center, My Duc Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Embryologists are blinded to individual clinical treatment allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2022
• First Posted: November 1, 2022
• Study Start: January 2, 2023
• Primary Completion: July 10, 2023
• Study Completion: April 25, 2024
• Last Updated: December 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)