NCT05600972

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

Completed NA Last updated 27 December 2024

What this trial tests

NA trial testing FSH priming in in Vitro Maturation in 120 participants. Completed in 25 April 2024.

Timeline

2 January 2023

Primary endpoint
10 July 2023

25 April 2024

Quick facts

Lead sponsor	Mỹ Đức Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	120
Start date	2 January 2023
Primary completion	10 July 2023
Estimated completion	25 April 2024
Sites	1 location across Vietnam

Drugs / interventions tested

• FSH priming

Conditions studied

• in Vitro Maturation — all drugs for in Vitro Maturation →
• FSH Priming — all drugs for FSH Priming →

Sponsor

Mỹ Đức Hospital

Who can join

Adults 18 to 37, female only, with in Vitro Maturation or FSH Priming. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Hormone-free vs. follicle-stimulating hormone-primed infertility treatment of women with polycystic ovary syndrome using biphasic in vitro maturation: a randomized controlled trial.
   Vuong LN, Ho VNA, Le AH, Nguyen NT, et al · · 2025 · cited 6× · PMID 39260537 · DOI 10.1016/j.fertnstert.2024.09.010