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

Infertility Clinical Trial

— LH/M2-Oocyte  

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)?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01595334
• Other study ID #: MB/LH-M2/OM/2011
• Status: Recruiting
• Phase: N/A
• First received: April 27, 2012
• Last updated: May 24, 2012
• Start date: April 2012
• Est. completion date: November 2012

Study information

• Verified date: May 2012
• Source: Southern Cross Fertility Centre
• Contact: Manchi Bharucha, Ph.D.
• Phone: 91-9892211941
• Email: drmanchi41[@]gmail.com
• Is FDA regulated: No
• Health authority: India: Indian Council of Medical Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infertility

Intervention

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

Locations

Country	Name	City	State
India	Sat Kaival Hospital Pvt. Ltd.	Anand	Gujarat
India	Disha Fertility & Surgical Hospital	Indore	Madhya Pradesh
India	Southern Cross Fertility Center	Mumbai	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
Southern Cross Fertility Centre	Disha Fertility and Surgical Centre,Indore,India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No