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Dual FSH/HCG Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT02739516
Recruitment Status : Completed
First Posted : April 15, 2016
Last Update Posted : May 19, 2016
Sponsor:
Information provided by (Responsible Party):
Ahmed Walid Anwar Murad, Benha University

Brief Summary:
The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .

Condition or disease Intervention/treatment Phase
Unexplained Infertility Drug: Human chorionic gonadotropin Drug: FSH co-trigger Drug: Letrozole Phase 3

Detailed Description:

This prospective randomized controlled study included 108 women with unexplained infertility recruited among those attending the Gynecology Outpatient Clinics of, Benha University Hospital, and private settings, Alkalubia, Egypt from Jun 2013 to Aug 2015. The study protocol was approved by the Local Ethics Committee and written informed consents were taken from both partners before starting of the study.

All women received the same regimen of ovarian stimulation using Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5 mg tab twice daily for 5 days starting from cycle day 3. Transvaginal ultrasound scan (TVS) was performed daily from cycle day 9 and a total of 10,000 IU of hCG (Epifasi, EPICO) was administered to those in whom at least one ovarian follicle was ≥18 mm in size. On the day of hCG administration women were randomly categorized into two groups according to a computer generated random numerical table. Envelopes containing the allocation information were chosen sequentially by patient herself in presence of her husband. Group A received FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once on day of hCG injection and group B received no FSH on day of hCG injection. Intrauterine insemination was performed 36 hours after HCG injection. Women in both groups received luteal phase support in the form of vaginal progesterone, (Prontogest 400 mg Vaginal Pessaries, IBSA) twice a day, starting from the day after IUI and continued till the eighth week, if the pregnancy test was positive.Two weeks later, quantitative ßhCG was estimated to diagnose chemical pregnancy. However, TVS was performed 4 weeks after positive pregnancy test to confirm clinical pregnancy by the presence of gestational sac with fetal echoes and pulsation and to exclude ectopic pregnancy. All women enrolled in the study underwent the study protocol for three consecutive cycles unless got pregnant.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Concomitant Administration of Follicle-stimulating Hormone at the Time of Human Chorionic Gonadotropin Trigger in Letrozole Stimulated Intrauterine Insemination Cycles in Women With Unexplained Infertility
Study Start Date : June 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arm Intervention/treatment
Active Comparator: Control
In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).
Drug: Human chorionic gonadotropin
In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.

Drug: Letrozole
Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.

Experimental: Study
In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .
Drug: Human chorionic gonadotropin
In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.

Drug: FSH co-trigger
In letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.

Drug: Letrozole
Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.




Primary Outcome Measures :
  1. Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W) [ Time Frame: Throughout the study completion; up to 3 months ]
    Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound


Secondary Outcome Measures :
  1. Frequency of ovarian hyperstimulation syndrome (OHSS) [ Time Frame: Throughout the study completion; up to 3 months ]
    Number of participants developed ovarian hyperstimulation syndrome (OHSS) per all women received intervention

  2. Multiple pregnancies [ Time Frame: Throughout the study completion; up to 3 months ]
    Number of participants had multiple pregnancy per women achieved pregnancy .

  3. The live birth rate per woman (LB/W). [ Time Frame: Throughout the study completion; up to 2 year ]
    Number of live birth per women receiving intervention.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unexplained infertility for more than 2 years
  • Normal ovulation proved by midluteal serum progesterone level >5 ng/ml,
  • Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
  • Normal semen analysis according to the modified World Health Organization (WHO) criteria
  • Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.

Exclusion Criteria:

  • Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
  • Ovarian cysts,
  • FSH >10 mIU/ml.
  • Previous intrauterine insemination (IUI )cycles,
  • Liver or kidney diseases,
  • Hypersensitivity to the used medications.

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): NCT02739516


Sponsors and Collaborators
Benha University
Investigators
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Principal Investigator: Ahmed Walid Anwar Murad, MD Gynecology & Obstetric Department, Faculty of Medicine, Benha University

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Responsible Party: Ahmed Walid Anwar Murad, Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine, Benha University, Benha University
ClinicalTrials.gov Identifier: NCT02739516     History of Changes
Other Study ID Numbers: Benha 125
First Posted: April 15, 2016    Key Record Dates
Last Update Posted: May 19, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Chorionic Gonadotropin
Infertility
Genital Diseases, Male
Genital Diseases, Female
Letrozole
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Reproductive Control Agents