Infertility
Conditions
Keywords
IVF-ET, ICSI, Gonadotrophins, rFSH, rLH, Cetrorelix, Leuprolide acetate
Brief summary
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.
Detailed description
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.
Interventions
DRUGCetrorelix
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
DRUGLuprolide Acetate
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
Sponsors
Disha Fertility and Surgical Centre,Indore,India
Southern Cross Fertility Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women aged 18-40 years * Primary or secondary infertility * Desire to achieve pregnancy * Basal FSH \<12 mIU/ML * Moderate to good ovarian reserve (antimullerian hormone (AMH) \>1ng/ml, and/ or antral follicle count (AFC)\>8 between both ovaries) * Informed written consent from both partners * BMI \<35 kg/mtr.sq. * No genetic abnormality
Exclusion criteria
* Hormonal preparation taken within 3 month prior to recruitment * Women with previous poor response to gonadotrophins * History of previous 3 or more miscarriages * Women with uncorrected tubal/uterine pathology * Women opting for assisted procedures like embryo hatching etc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of mature oocytes immediately after oocyte recovery | Women would be followed every 2 weeks upto 6 weeks after embryo transfer | Number of mature oocytes would be measured immediately after the oocyte recovery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical pregnancy | Women would be followed every 2 weeks upto 6 weeks after embryo transfer | Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation. |
Countries
India
Contacts
Primary ContactManchi Bharucha, Ph.D.
Backup ContactNayna Patel
Outcome results
None listed