Infertility Clinical Trial
Official title:
Is it Possible to Obtain Higher Yield of Mature M2 Oocytes by Establishing Appropriate Levels of LH During Controlled Ovarian Hyperstimulation (COH) in Antagonist Cycles for In-vitro Fertilization-embryo Transfer (IVF-ET)/ Intracytoplasmic Sperm Injection (ICSI)?
1. Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions
during menstrual cycle at appropriate plasma levels'
2. In early follicular phase,in the requisite range,LH is known to contribute to
maturation of oocyte during transition phase from metaphase-1(M1) to metaphase-2 (M2).
3. If during this transition, appropriate level of LH can be maintained either through the
use of gonadotropin releasing hormone (GnRH) antagonist if found excessive or
supplementation with exogenous LH, if found deficient, maturation process can be
enhanced.
4. Further maintenance of suitable combination of recombinant follicle stimulating hormone
(rFSH) + rLH can help in realizing higher yield of mature M2 oocytes,with higher
probability of establishing clinical pregnancy.
The study is planned to assess whether maintenance of levels of LH through the use of GnRH
antagonist would contribute to obtaining mature M2 oocytes so that maximum number of good
quality embryo's with potential to implant is obtained.
The mature oocytes would be subjected to either standard in-vitro fertilization (IVF) or
intracytoplasmic sperm injection (ICSI) depending on the status of the male factor.
The objective would be to obtain good quality embryo's with implantation potential for fresh
embryo transfer and/or subsequent frozen thaw embryo transfer.
In both these events, the secondary outcome measures would be establishment of clinical
pregnancy by transvaginal ultrasound performed 6 weeks after embryo transfer.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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