Clinical trial NCT01595334: Study on Influence of Leutinizing Hormone (LH) on Oocyte Maturity
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
Overall status: UNKNOWN
Phase: NA
Conditions: Infertility
Keywords: IVF-ET
ICSI
Gonadotrophins
rFSH
rLH
Cetrorelix
Leuprolide acetate
Lead sponsor: Southern Cross Fertility Centre
Sponsor class: OTHER
Collaborators: name: Disha Fertility and Surgical Centre,Indore,India
First posted: 2012-05-10
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Number of mature oocytes immediately after oocyte recovery
timeFrame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer
Secondary outcomes:
measure: Clinical pregnancy
timeFrame: Women would be followed every 2 weeks upto 6 weeks after embryo transfer
Other outcomes:
Locations:
city: Anand
country: India
facility: Sat Kaival Hospital Pvt. Ltd.
state: Gujarat
city: Indore
country: India
facility: Disha Fertility & Surgical Hospital
state: Madhya Pradesh
city: Mumbai
country: India
facility: Southern Cross Fertility Center
state: Maharashtra
Study officials:
affiliation: Sat Kaival Pvt. Ltd, Anand, Gujarat
name: M R Bharucha, PhD
role: STUDY_DIRECTOR
affiliation: Sat Kaival Hospital Pvt. Ltd, Anand, Guajarat
name: Nayana Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Southern Cross Fertility Center, Mumbai, India
name: Faram Irani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Disha Fertility & Surgical Hospital, Indore, India
name: Asha Baxi, MD, FRCOG
role: PRINCIPAL_INVESTIGATOR
References: