FSH/LH Ratio as a Predictor of IVF Outcome in Young and Older Women

NCT02674178 | Completed Phase 4 DMC

• 1 other identifier: 145
• Study Type: interventional
• Target: 235
• Locations: 1 country
• Sites: 1

Brief Summary

All women had normal uterine cavity determined by previous hysterosalpingography or hysteroscopy. Women with abnormally low Gn as hypothalamic hypogonadism , High LH as PCOS and women with abnormal endocrine functions as abnormal thyroid or adrenal functions were excluded. Any woman with ovarian cyst or azopermic male partner was also excluded. The patients were subjected to history taking, including age, duration, type and cause of infertility and medical history. Full examination including general and abdominal and vaginal examination was done followed by ultrasound evaluation for presence of 3 or more pre-antral follicles and exclusion of ovarian cysts. Basal day 3 hormonal evaluation for FSH, LH and E2 in a natural cycle was done. E2, FSH and LH levels were determined using Immulite system (Siemens Healthcare diagnostics,UK).The intra- and inter-assay coefficients of variation were 15% and 16% for E2, 4.8% and 26% for LH. FSH analytical sensitivity was 0.1 mIU/ml. All participants underwent long protocol. Daily SC injection of Triptorelin : Decapeptyl 0.1 mg (Ferring, Switzerland) 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG injection. Gn stimulation started after fulfilling stimulation start criteria of thin endometrium \< 5 mm and low E2 \< 50 and LH \< 5IU/l \[18\] with either HMG(Menogon; Ferring, Switzerland) or rFSH (Gonal-f; Merck Serono, Germany) in a starting dose of 150-300 IU/day depending on patients age and previous gonadotropin response. then the dose was adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on alternate days according to the ovarian response to treatment starting on treatment cycle day (6) for folliculometry and endometrial thickness and pattern. Triggering by HCG 10000 IU IM (Pregnyl, Organon, the Netherlands) when at least 2 follicles reached a mean diameter of 18 mm \[18\] Cycle cancellation was decided when transvaginal ultrasound scan on cycle day (9) revealed no adequate follicular growth (\<3 mature follicles). Ovum pick-up (OPU) was done 34-36 hours after hCG injection under transvaginal ultrasound guide.

Conditions

Invitro Fertilization

Outcome Measures

Primary Outcomes (1)

• clinical pregnancy

  the presence of gestational sac containing fetal hearts on ultrasound scan

  14 days after embryo transfer

Secondary Outcomes (3)

• multiple pregnancy

  14 days after embryo transfer

• Abortion cases per pregnancies

  12 weeks after ET

• ectopic cases per pregnancies

  4 weeks after ET

Study Arms (2)

Age <35

ACTIVE COMPARATOR

\< 35 years old included 201 women who are further subdivided according o FSH/LH ratio into G1A (201 patients) with FSH/LH ratio \<2 and G1B (37 patients) with FSH/LH ratio ≥2.

Procedure: Invitro fertilization

Age ≥ 35

ACTIVE COMPARATOR

. Group 2 ≥ 35 years old included 34 women who are further subdivided according o FSH/LH ratio into G2A (25 patients) with FSH/LH ratio \<2 and G2B (9 patients) with FSH/LH ratio ≥2

Procedure: Invitro fertilization

Interventions

Invitro fertilization PROCEDURE

All participants underwent long protocol. Daily SC injection of Triptorelin 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG injection. Gn stimulation started in a starting dose of 150-300 IU/day depending on patients age and previous gonadotropin response. then the dose was adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on alternate days Triggering by HCG 10000 IU IM when at least 2 follicles reached a mean diameter of 18 mm \[18\] Ovum pick-up (OPU) was done 34-36 hours after hCG injection Transfer of cleaving embryos was done on day 3 after oocyte retrieval

Age <35; Age ≥ 35

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• less than 41 years old , with normal menstrual cycle with a range of 24 - 35 days with day 3 FSH less than 10 mIU/ml in natural cycle and normal serum prolactin . All women had normal uterine cavity determined by previous hysterosalpingography or hysteroscopy

You may not qualify if:

• Women with abnormally low Gn as hypothalamic hypogonadism , High LH as PCOS and women with abnormal endocrine functions as abnormal thyroid or adrenal functions were excluded. Any woman with ovarian cyst or azopermic male partner was also excluded.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Kasr Alainy medical school

Cairo, Cairo Governorate, 12151, Egypt

Location

Study Officials

• Ahmed Maged, MD

  Kasr Alainy medical school

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 31, 2016
• First Posted: February 4, 2016
• Study Start: June 1, 2012
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: February 4, 2016

Record last verified: 2016-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)