MATERIALS AND METHODS
PCOS
GROUP B, UNEXPLAINED INFERTILITY, RECRUITMENT, CAVITY, BLOOD
This prospective, randomized non-blinded controlled trial was carried out at the ART
Center, Department of Obstetrics and Gynecology, of a tertiary care center from
January 2020 to August 2021. After obtaining ethical clearance, a total of 100 women
were enrolled in the study. With informed consent, women between the ages of 21 and
38 years with either tubal factor, male factor or unexplained infertility, with a
normal ovarian reserve, were included in the study; women with a thin endometrium,
prior history of uterine anomaly/surgery, PCOS, poor ovarian reserve [antral
follicle count (AFC)<5 and/or serum anti-Müllerian hormone (AMH) levels
<1.2 ng/ml] and known medical comorbidities such as diabetes/hypertension were
excluded from the study. Prior to recruitment into an IVF cycle, baseline hormone
profile [day-2/3 luteinizing hormone (LH), follicle stimulating hormone (FSH),
prolactin (Prl), thyroid stimulating hormone (TSH) and AMH], 4-D ultrasound for
uterine cavity assessment, day-2-5 AFC and day-16 endometrial thickness were
assessed. Randomization was performed using a computer-generated random number table
in a 1:1 ratio at the time of administration of trigger to either receive the hCG
trigger or the dual (hCG + Leuprolide) trigger. Neither the patients nor the
investigators of the study were blinded.Sample size was calculated based on a previous study by Controlled ovarian stimulation with flexible antagonist protocol was started for
patients meeting the inclusion criteria. Baseline USG was performed on day 2 of the
cycle. Recombinant FSH (Gonal F, Merck Serono, Mumbai, India) was started from day 2
or day 3 of the menstrual cycle. Gonadotropin dose was decided based on patient age,
BMI, and ovarian reserve parameters. Ultrasonographic assessment by transvaginal
sonography was started from day 5 of stimulation. GnRH antagonist cetrorelix acetate
(Injection Cetrotide, Merck Serono Specialties Pvt. Ltd., India) 250ug was added on
the 6On the day of trigger administration, the patients were randomized to either of the
two groups of the study. Group A (n=50) received the single trigger with a
subcutaneous injection of r-hCG (Inj Ovitrelle, Merck Serono, Mumbai, India) 250
µg. Group B (n=50) received the dual trigger with an injection of Leuprolide
(Inj. Lupride, Sun Pharmaceuticals Industries Ltd.) 1 mg subcutaneously
simultaneously with an injection of r-hCG (Inj. Ovitrelle, Merck Serono, Mumbai,
India) 250 µg subcutaneously. Blood samples were drawn 12 hours later to
evaluate LH levels.Oocyte retrieval will be performed 36-37 h post trigger, followed by in-vitro sperm
insemination. Post fertilization, 1 or 2 embryos were transferred between days 3 and
5, depending on patient response and embryo quality. All embryo transfers were
performed by a single fellowship-trained senior faculty under abdominal
ultrasonography guidance using an embryo catheter. Both groups received luteal phase
support with intramuscular injections of progesterone 100 mg once daily or
micronized progesterone vaginal pessary 600mg daily in two divided doses. Pregnancy
tests were considered positive when positive serum hCG levels (> 30 IU/ml) were
detected 14 days after embryo transfer. Clinical pregnancy was defined by a viable
intrauterine gestation in the 6-week scan. Multiple gestational sacs were counted as
one clinical pregnancy. The clinical pregnancy rate was calculated as the number of
clinical pregnancies per embryo (