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| Name | Class |
|---|---|
| Disha Fertility and Surgical Centre,Indore,India | UNKNOWN |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study subjects desiring pregnancy | Active Comparator | 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. |
|
| Control subjects desiring pregnancy | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix | Drug | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of mature oocytes immediately after oocyte recovery | Number of mature oocytes would be measured immediately after the oocyte recovery | Women would be followed every 2 weeks upto 6 weeks after embryo transfer |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical pregnancy | Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation. | Women would be followed every 2 weeks upto 6 weeks after embryo transfer |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Manchi Bharucha, Ph.D. | Contact | 91-9892211941 | drmanchi41@gmail.com | |
| Nayna Patel | Contact | 91-02692650090 | minipatel2000@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| M R Bharucha, PhD | Sat Kaival Pvt. Ltd, Anand, Gujarat | Study Director |
| Nayana Patel, MD | Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sat Kaival Hospital Pvt. Ltd. | Recruiting | Anand | Gujarat | India |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C062876 | cetrorelix |
| C493311 | luprolide acetate gel depot |
| D016729 | Leuprolide |
| ID | Term |
|---|---|
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
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| Luprolide Acetate | Drug | Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection |
|
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| Faram Irani, MD |
| Southern Cross Fertility Center, Mumbai, India |
| Principal Investigator |
| Asha Baxi, MD, FRCOG | Disha Fertility & Surgical Hospital, Indore, India | Principal Investigator |
| Disha Fertility & Surgical Hospital | Recruiting | Indore | Madhya Pradesh | India |
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| Southern Cross Fertility Center | Recruiting | Mumbai | Maharashtra | India |
|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |