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

Primary Purpose

Infertility

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Cetrorelix
Luprolide Acetate
Sponsored by
Southern Cross Fertility Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring IVF-ET, ICSI, Gonadotrophins, rFSH, rLH, Cetrorelix, Leuprolide acetate

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Sat Kaival Hospital Pvt. Ltd.Recruiting
  • Disha Fertility & Surgical HospitalRecruiting
  • Southern Cross Fertility CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Study subjects desiring pregnancy

Control subjects desiring pregnancy

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of mature oocytes immediately after oocyte recovery
Number of mature oocytes would be measured immediately after the oocyte recovery

Secondary Outcome Measures

Clinical pregnancy
Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation.

Full Information

First Posted
April 27, 2012
Last Updated
May 24, 2012
Sponsor
Southern Cross Fertility Centre
Collaborators
Disha Fertility and Surgical Centre,Indore,India
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1. Study Identification

Unique Protocol Identification Number
NCT01595334
Brief Title
Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity
Acronym
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)?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2012
Overall Recruitment Status
Unknown status
Study Start Date
April 2012 (undefined)
Primary Completion Date
September 2012 (Anticipated)
Study Completion Date
November 2012 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Southern Cross Fertility Centre
Collaborators
Disha Fertility and Surgical Centre,Indore,India

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
IVF-ET, ICSI, Gonadotrophins, rFSH, rLH, Cetrorelix, Leuprolide acetate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Study subjects desiring pregnancy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control subjects desiring pregnancy
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Cetrorelix
Other Intervention Name(s)
Cetrotide
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Luprolide Acetate
Other Intervention Name(s)
Lupron
Intervention Description
Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
Primary Outcome Measure Information:
Title
Number of mature oocytes immediately after oocyte recovery
Description
Number of mature oocytes would be measured immediately after the oocyte recovery
Time Frame
Women would be followed every 2 weeks upto 6 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Clinical pregnancy
Description
Diagnosed by transvaginal ultrasound.Appearance of yolk sac with fetal heart beat at 6 weeks of gestation.
Time Frame
Women would be followed every 2 weeks upto 6 weeks after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Manchi Bharucha, Ph.D.
Phone
91-9892211941
Email
drmanchi41@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nayna Patel
Phone
91-02692650090
Email
minipatel2000@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M R Bharucha, PhD
Organizational Affiliation
Sat Kaival Pvt. Ltd, Anand, Gujarat
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Nayana Patel, MD
Organizational Affiliation
Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Faram Irani, MD
Organizational Affiliation
Southern Cross Fertility Center, Mumbai, India
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Asha Baxi, MD, FRCOG
Organizational Affiliation
Disha Fertility & Surgical Hospital, Indore, India
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sat Kaival Hospital Pvt. Ltd.
City
Anand
State/Province
Gujarat
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nayana Patel, MD
First Name & Middle Initial & Last Name & Degree
Nayana Patel;, MD
Facility Name
Disha Fertility & Surgical Hospital
City
Indore
State/Province
Madhya Pradesh
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Asha Baxi, MD, FRCOG
First Name & Middle Initial & Last Name & Degree
Asha Baxi, MD, FRCOG
Facility Name
Southern Cross Fertility Center
City
Mumbai
State/Province
Maharashtra
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faram Irani, MD
First Name & Middle Initial & Last Name & Degree
Faram Irani, MD

12. IPD Sharing Statement

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

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