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Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity

NCT01595334 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-05-25

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

DRUG

Luprolide Acetate

Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection

Sponsors & Collaborators

  • Disha Fertility and Surgical Centre,Indore,India

    collaborator UNKNOWN

  • Southern Cross Fertility Centre

    lead OTHER

Principal Investigators

  • M R Bharucha, PhD · Sat Kaival Pvt. Ltd, Anand, Gujarat

  • Nayana Patel, MD · Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat

  • Faram Irani, MD · Southern Cross Fertility Center, Mumbai, India

  • Asha Baxi, MD, FRCOG · Disha Fertility & Surgical Hospital, Indore, India

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2012-09-30
Completion
2012-11-30

Countries

  • India

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01595334 on ClinicalTrials.gov