Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity
NCT ID: NCT01595334
Last Updated: 2012-05-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
300 participants
INTERVENTIONAL
2012-04-30
2012-11-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
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.
Luprolide Acetate
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
Interventions
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Cetrorelix
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
Luprolide Acetate
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
40 Years
FEMALE
Yes
Sponsors
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Disha Fertility and Surgical Centre,Indore,India
UNKNOWN
Southern Cross Fertility Centre
OTHER
Responsible Party
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Principal Investigators
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M R Bharucha, PhD
Role: STUDY_DIRECTOR
Sat Kaival Pvt. Ltd, Anand, Gujarat
Nayana Patel, MD
Role: PRINCIPAL_INVESTIGATOR
Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat
Faram Irani, MD
Role: PRINCIPAL_INVESTIGATOR
Southern Cross Fertility Center, Mumbai, India
Asha Baxi, MD, FRCOG
Role: PRINCIPAL_INVESTIGATOR
Disha Fertility & Surgical Hospital, Indore, India
Locations
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Sat Kaival Hospital Pvt. Ltd.
Anand, Gujarat, India
Disha Fertility & Surgical Hospital
Indore, Madhya Pradesh, India
Southern Cross Fertility Center
Mumbai, Maharashtra, India
Countries
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Central Contacts
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Facility Contacts
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Nayana Patel, MD
Role: primary
Asha Baxi, MD, FRCOG
Role: primary
Faram Irani, MD
Role: primary
Other Identifiers
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MB/LH-M2/OM/2011
Identifier Type: -
Identifier Source: org_study_id
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