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

NCT01595334 | Unknown DMC

• 1 other identifier: MB/LH-M2/OM/2011
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 3

Brief Summary

1. 1.Leutinizing hormone (LH) has been demonstrated to exert variable physiological actions during menstrual cycle at appropriate plasma levels'
2. 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. 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. 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

Infertility

Keywords

IVF-ET; ICSI; Gonadotrophins; rFSH; rLH; Cetrorelix; Leuprolide acetate

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Clinical pregnancy

  Women would be followed every 2 weeks upto 6 weeks after embryo transfer

Study Arms (2)

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.

Drug: Cetrorelix

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.

Drug: Luprolide Acetate

Interventions

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

Also known as: Cetrotide

Study subjects desiring pregnancy

Luprolide Acetate DRUG

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

Also known as: Lupron

Control subjects desiring pregnancy

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Southern Cross Fertility Centre: lead
• Disha Fertility and Surgical Centre,Indore,India: collaborator

Study Sites (3)

Sat Kaival Hospital Pvt. Ltd.

Anand, Gujarat, India

RECRUITING

Disha Fertility & Surgical Hospital

Indore, Madhya Pradesh, India

RECRUITING

Southern Cross Fertility Center

Mumbai, Maharashtra, India

RECRUITING

MeSH Terms

Conditions

Infertility

Interventions

cetrorelix; luprolide acetate gel depot; Leuprolide

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• M R Bharucha, PhD

  Sat Kaival Pvt. Ltd, Anand, Gujarat

  STUDY DIRECTOR

• Nayana Patel, MD

  Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat

  PRINCIPAL INVESTIGATOR

• Faram Irani, MD

  Southern Cross Fertility Center, Mumbai, India

  PRINCIPAL INVESTIGATOR

• Asha Baxi, MD, FRCOG

  Disha Fertility & Surgical Hospital, Indore, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Manchi Bharucha, Ph.D.

CONTACT

91-9892211941; drmanchi41@gmail.com

Nayna Patel

CONTACT

91-02692650090; minipatel2000@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 10, 2012
• Study Start: April 1, 2012
• Primary Completion: September 1, 2012
• Study Completion: November 1, 2012
• Last Updated: May 25, 2012

Record last verified: 2012-05

Locations

IN (3)