Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity (LH/M2-Oocyte)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01595334
Recruitment Status : Unknown
Verified May 2012 by Southern Cross Fertility Centre.
Recruitment status was:  Recruiting
First Posted : May 10, 2012
Last Update Posted : May 25, 2012
Disha Fertility and Surgical Centre,Indore,India
Information provided by (Responsible Party):
Southern Cross Fertility Centre

Brief 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.

Condition or disease Intervention/treatment
Infertility Drug: Cetrorelix Drug: Luprolide Acetate

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)?
Study Start Date : April 2012
Estimated Primary Completion Date : September 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 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.

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
Other Name: Cetrotide
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.

Drug: Luprolide Acetate
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
Other Name: Lupron

Primary Outcome Measures :
  1. Number of mature oocytes immediately after oocyte recovery [ Time Frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer ]
    Number of mature oocytes would be measured immediately after the oocyte recovery

Secondary Outcome Measures :
  1. Clinical pregnancy [ Time Frame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer ]
    Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01595334

Contact: Manchi Bharucha, Ph.D. 91-9892211941
Contact: Nayna Patel 91-02692650090

Sat Kaival Hospital Pvt. Ltd. Recruiting
Anand, Gujarat, India
Contact: Nayana Patel, MD         
Principal Investigator: Nayana Patel;, MD         
Disha Fertility & Surgical Hospital Recruiting
Indore, Madhya Pradesh, India
Contact: Asha Baxi, MD, FRCOG         
Principal Investigator: Asha Baxi, MD, FRCOG         
Southern Cross Fertility Center Recruiting
Mumbai, Maharashtra, India
Contact: Faram Irani, MD         
Principal Investigator: Faram Irani, MD         
Sponsors and Collaborators
Southern Cross Fertility Centre
Disha Fertility and Surgical Centre,Indore,India
Study Director: M R Bharucha, PhD Sat Kaival Pvt. Ltd, Anand, Gujarat
Principal Investigator: 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

Responsible Party: Southern Cross Fertility Centre Identifier: NCT01595334     History of Changes
Other Study ID Numbers: MB/LH-M2/OM/2011
First Posted: May 10, 2012    Key Record Dates
Last Update Posted: May 25, 2012
Last Verified: May 2012

Keywords provided by Southern Cross Fertility Centre:
Leuprolide acetate

Additional relevant MeSH terms:
Genital Diseases, Male
Genital Diseases, Female
Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists