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NCT05600972
Non-FSH vs FSH-priming in Cycles With CAPA-IVM Treatment
Conditions: in Vitro Maturation, FSH Priming
Sex: Female
Ages: 18 Years – 37 Years
Phase: NA
Enrollment: 120
Sponsor: Mỹ Đức Hospital
Location: Vietnam
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.
Eligibility Criteria
Inclusion Criteria:Aging from 18 to 37Diagnosed with PCOS followed by Rotterdam criteriaHaving an indication for CAPA-IVM treatmentAgree to have all embryos frozen on day 5Agree 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 transferHaving ≤ 2 IVM/IVF attemptsExclusion Criteria:A previous ovarian stimulation (for OI or IVF) within the previous three monthsCycles with oocytes donationUterine or ovarian abnormalitiesPrevious evidence of a very low oocyte maturation without suspicion of FSH /LH receptor defectCycles with sperms retrieved after PESA/TESE/microTESE
Source: ClinicalTrials.gov (NCT05600972). StuddyBuddy aggregates publicly available trial information.