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

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ClinicalTrials.gov Identifier: NCT02674178
Recruitment Status : Completed
First Posted : February 4, 2016
Last Update Posted : February 4, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Maged, Cairo University

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.


Condition or disease Intervention/treatment Phase
Invitro Fertilization Procedure: Invitro fertilization Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 235 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: FSH/LH Ratio as a Predictor of IVF Outcome in Young and Older Women
Study Start Date : June 2012
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Arm Intervention/treatment
Active Comparator: Age <35
< 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

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


Active Comparator: Age ≥ 35
. 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

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





Primary Outcome Measures :
  1. clinical pregnancy [ Time Frame: 14 days after embryo transfer ]
    the presence of gestational sac containing fetal hearts on ultrasound scan


Secondary Outcome Measures :
  1. multiple pregnancy [ Time Frame: 14 days after embryo transfer ]
  2. Abortion cases per pregnancies [ Time Frame: 12 weeks after ET ]
  3. ectopic cases per pregnancies [ Time Frame: 4 weeks after ET ]


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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02674178


Locations
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Egypt
Kasr Alainy medical school
Cairo, Egypt, 12151
Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Ahmed Maged, MD Kasr Alainy medical school

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Responsible Party: Ahmed Maged, Assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT02674178     History of Changes
Other Study ID Numbers: 145
First Posted: February 4, 2016    Key Record Dates
Last Update Posted: February 4, 2016
Last Verified: February 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No