Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity (LH/M2-Oocyte)
- Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions during menstrual cycle at appropriate plasma levels'
- 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).
- 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.
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)?|
- Number of mature oocytes immediately after oocyte recovery [ Time Frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer ] [ Designated as safety issue: No ]Number of mature oocytes would be measured immediately after the oocyte recovery
- Clinical pregnancy [ Time Frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer ] [ Designated as safety issue: No ]Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation.
|Study Start Date:||April 2012|
|Estimated Study Completion Date:||November 2012|
|Estimated Primary Completion Date:||September 2012 (Final data collection date for primary outcome measure)|
Active Comparator: Study subjects desiring pregnancy
Study subjects to be treated with rFSH, rLH throughout controlled ovarian hyperstimulation (COH) in appropriate dosages,considering age, body mass index (BMI), ovarian reserve, etc. and GnRH antagonist, cetrorelix in 0.25 mg/d when needed till the desired follicular maturity and the minimum required number of follicles are achieved.
INTRVENTIONS - Monitoring at regular intervals by transvaginal ultrasound and hormonal studies.Once pregnancy established by beta-human chorionic gonadotropin (hCG) and ultrasound will be supported by intervention of adequate luteal support by estrogen (E) + progesterone (P) for 12 weeks of gestation.
Cetrorelix 0.25 mg/d would be administered by subcutaneous injection to women when the plasma LH is higher (>4.5 mIU/ml) in the study arm
Other Name: Cetrotide
Control subjects desiring pregnancy
Control subjects selected in randomized way,desiring pregnancy will be treated with gonadotrophins, rFSH and rLH in appropriate dosages considering age, BMI, ovarian reserve, etc. after standard downregulation with GnRH agonist, Leuprolide acetate, 1 mg/d under established `Long Luteal Suppression Protocol` from the previous cycle.
INTERVENTIONS - Monitoring of response to treatment by hormonal study and sonography evaluation at regular intervals during COH till adequate number of mature follicles of minimum 18 mm mean diameter is achieved, to be followed by hCG trigger and ovum pick-up (OPU) and embryo transfer (ET). Chemical pregnancy by beta-hCG would be confirmed 14 days post-ET. Clinical pregnancy would be confirmed by sonography 6 weeks after ET (visibility of yolk sac and fetal heart-beat). Pregnancy support by E+P for 12 weeks would be provided.
Drug: Luprolide Acetate
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
Other Name: Lupron
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.
|Contact: Manchi Bharucha, Ph.D.||firstname.lastname@example.org|
|Contact: Nayna Patelemail@example.com|
|Sat Kaival Hospital Pvt. Ltd.||Recruiting|
|Anand, Gujarat, India|
|Contact: Nayana Patel, MD|
|Principal Investigator: Nayana Patel;, MD|
|Disha Fertility & Surgical Hospital||Recruiting|
|Indore, Madhya Pradesh, India|
|Contact: Asha Baxi, MD, FRCOG|
|Principal Investigator: Asha Baxi, MD, FRCOG|
|Southern Cross Fertility Center||Recruiting|
|Mumbai, Maharashtra, India|
|Contact: Faram Irani, MD|
|Principal Investigator: Faram Irani, MD|
|Study Director:||M R Bharucha, PhD||Sat Kaival Pvt. Ltd, Anand, Gujarat|
|Principal Investigator:||Nayana Patel, MD||Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat|
|Principal Investigator:||Faram Irani, MD||Southern Cross Fertility Center, Mumbai, India|
|Principal Investigator:||Asha Baxi, MD, FRCOG||Disha Fertility & Surgical Hospital, Indore, India|