To evaluate the efficacy and cost effectiveness of Two Treatment regimens for treating women requiring Invitro Fertilisation

Phase 4

• Conditions: Female infertility, unspecified, Infertility requiring IVF,

• Registration Number: CTRI/2009/091/000086
• Lead Sponsor: Indian Society of Assisted Reproduction ISAR

Brief Summary

This study is a randomised open label multi-centre trial to compare the efficacy and safety of the Minimal stimulation protocol vis-a-vis the standard protocol for artificial reproduction (using ICSI) with rFSH (Foligraf), manufactured by Bharat Serums and Vaccines Ltd. The study is being conducted at 24 centres in India. Thr primary outcome is number of grade 1 oocytes and mean percentage of fertilisation rate. The secondary outcomes are percentage of clinical pregnancy, mean dose of rFSH and incidence of AEs.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

• 1.Women in the age group of 18 37 years (both inclusive) with normal ovulatory cycles 2.Women with body mass index (BMI) between 20 and 30 kg/m2 3.Women with primary or secondary Infertility 4.Women with negative urine pregnancy test (UPT) 5.Women with normal or clinically insignificant hematology and blood chemistry values.
• 6.Women whose male partner does not require surgical sperm retrieval [Percutaneous epididymal sperm aspiration (PESA) or Testicular epididymal sperm aspiration (TESA)].
• 7.Women with FSH, LH, Estradiol (E2),Progesterone (P4) at luteal phase, and Prolactin levels within normal range 8.Women with both intact ovaries.
• Transvaginal ultrasound documenting the presence of both ovaries, without evidence of abnormality (e.g. no endometrioma) and normal adnexa (e.g. no hydrosalpinx) within 6 months before randomization 9.Male with normal sperm motility and sperm count more than 4 million/mL.

Exclusion Criteria

• Women with gonadal failure or premature ovarian failure2.
• Women with FSH >10 IU/L3.
• Women with thyroid or adrenal dysfunction4.
• Women with PCOS, endometrioma (endometrial thickness >4mm) or any other active pelvic pathology5.
• Women with untreated fibroid tumors of the uterus of <4 cm in size (incompatible with pregnancy), including untreated submucous myoma and 12 weeks adenomyomas6.
• Women with >3 previously unsuccessful IVF cycles or previous IVF cycle with unsuccessful fertilization7.
• Women with history of recurrent miscarriage8.
• Women with tumors of the ovary, breast, uterus, pituitary or hypothalamus and malformations of the sexual organs (incompatible with pregnancy)9.
• Women with history of diabetes or hypertension or any other systemic disorder and on treatment for the same10.
• Women with history of hypersensitivity to any excipients of the investigational products12.
• Women who have participated in another study or received any investigational product 30 days prior to enrolment or simultaneous participation in another clinical study14.
• Women who are poor responders to FSH 15.
• Women with complete or partial hysterectomy.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Mean percentage of grade 1 oocytes retrieved 2. Mean percentage of fertilization rate	4 weeks

Secondary Outcome Measures

Name	Time	Method
1. Mean total dose in IU required to achieve follicle size ≥18 mm in diameter (from the day of r-hFSH administration to the Day of Human Chorionic Gonadotropin [HCG] administration)2. Percentage of Clinical Pregnancy rate3. Number of mature and immature oocytes4. Ratio of mature and immature oocytes5. Number of grade I embryos6. Percentage of Chemical Pregnancy rate7. Mean days of stimulation with r-hFSH required to achieve follicle size ≥18 mm in diameter 8. Risk of OHSS 9. Incidence & Absolute Frequency of AE?s reported in the trial which were related to study drugs administered in Group A & Group B	4 weeks

Trial Locations

Locations (23)

Akansksha IVF; 🇮🇳 Anand, GUJARAT, India

Ashwini Maternity and Surgical Hospital; 🇮🇳 Mumbai, MAHARASHTRA, India

Asian Institute of Infertility Management & Dr. Shefali Jain Test Tube Baby Centre; 🇮🇳 Indore, MADHYA PRADESH, India

Babies & Us Fertility, IVF & ICSI Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Bangalore Assisted Conception Centre; 🇮🇳 Bangalore, KARNATAKA, India

Bansla Hospital & Safal Fertility Foundation; 🇮🇳 Ahmadabad, GUJARAT, India

Bavishi Fertility Institute; 🇮🇳 Ahmadabad, GUJARAT, India

Bombay Fertility Clinic and IVF Centre; 🇮🇳 Mumbai, MAHARASHTRA, India

Dr. Patil's Fertility and Endoscopic centre; 🇮🇳 Bangalore, KARNATAKA, India

Genesis Centre; 🇮🇳 Delhi, DELHI, India

Scroll for more (13 remaining)

Akansksha IVF

🇮🇳Anand, GUJARAT, India

Dr. Nayana Patel

Principal investigator

02692253789

nayana@ivfsurrogate.com