Health Condition 1: O269- Pregnancy related conditions, unspecified
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Control Intervention1: Nil: Nil
Sponsors
Gufic Biosciences Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Diagnosed with primary or secondary infertility and undergoing ART or IVF treatment. Anti Mullerian Hormone levels between 1.5 and 3.5 ng per mL, categorized as normal ovarian responders. Presence of both ovaries and absence of significant uterine cavity abnormalities on ultrasound or relevant imaging. Body Mass Index between 18.5 and 29.9 kg per metre square. Regular menstrual cycles which are 25 to 35 day cycle length for greater than or equal to 3 consecutive cycles prior to screening, confirming ovulatory function. Male partner with semen parameters adequate for IVF or ICSI or use of donor sperm where applicable. For prospective participants, ability and willingness to provide written informed consent for study participation and follow-up. For retrospective participants, availability of complete medical records documenting ovarian stimulation, embryology outcomes, and pregnancy outcomes. Receiving Puregraf, Menotas, or Humog as part of routine clinical practice.
Exclusion criteria
Exclusion criteria: Diagnosis of Polycystic Ovary Syndrome Uncontrolled thyroid dysfunction, hyperprolactinemia, or other metabolic or endocrine disorders that may affect hormonal regulation or reproductive outcomes. History of recurrent pregnancy loss with three or more previous miscarriages. Presence of severe endometriosis, rASRM Grade III to IV Active malignancy or history of ovarian cancer. Known hypersensitivity or contraindication to gonadotropin therapy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate and compare the effectiveness of three HMG preparations Puregraf Menotas and Humog on the biochemical pregnancy rate in women with infertility undergoing ARTTimepoint: 9 months retrospective review period and a 15 months prospective study period | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare the clinical pregnancy rate ongoing pregnancy rate follicular development number of oocytes retrieved fertilization rate proportion of high quality embryos total gonadotropin dose duration of ovarian stimulation live birth rate and the incidence of OHSS injection site reactions and other adverse drug reactions across the three HMG exposure groups.Timepoint: 9 months retrospective review period and a 15 months prospective study period | — |
Countries
India
Contacts
Public ContactDr Rohan Palshetkar
D.Y. Patil Fertility and IVF Centre
Outcome results
None listed