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Trial record 18 of 1991 for:    infertility AND (woman OR women OR female)

Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:

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ClinicalTrials.gov Identifier: NCT03476564
Recruitment Status : Not yet recruiting
First Posted : March 26, 2018
Last Update Posted : March 26, 2018
Sponsor:
Collaborators:
El Galaa Teaching Hospital
Benha University Hospital
Information provided by (Responsible Party):
Ahmed Amr Fayez, Benha University

Brief Summary:
Our findings will provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward female factor infertility treatment with pentoxyfylline.

Condition or disease Intervention/treatment Phase
Infertility, Female Drug: pentoxifylline Drug: Vit E Early Phase 1

Detailed Description:

This randomized clinical trial will be conducted on 140 infertile patients. The study is approved by the Ethical Committee of Benha obstetrics and Gynecology Department and will be initiated after achieving written consents of the participants. The study will include infertile patients under 39 years of age without a previous history of ICSI cycle. Exclusion criteria will be hypothalamic amenorrhea, drug reactions or complications, endometriosis and fibroids. Patients will be randomly divided into two equal groups. Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes. For each participant a questionnaire will be filled by the researchers. The questionnaire contained questions about age, duration of infertility, the type and cause of infertility. Data will be collected from questionnaires, clinical, laboratory notes and ultrasound reports. Endometrial thickness will be measured on the day of the HCG prescription in both groups by one of the two attending physicians. Chemical pregnancy will be detected by serum beta-hCG analysis 14 days after embryo transfer and transvaginal ultrasound scan will be scheduled 2 weeks later to confirm the diagnosis of clinical pregnancy. The intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.

Sample size calculation Sample size was calculated using PASS® version 11 program, setting the type-1 error (α) at 0.05 and the power (1-β) at 0.8. Results from a previous study (Ashraf alesyan, 2009) showed that the incidence of pregnancy rate among ttt group was 57.1% while for control group it was 39.2%, with an effect size of 12%. Calculation according to these values produced a minimal sample size of 131 cases in each group.

Results

Results will be statistically analyzed.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Endometrial thickness will be measured on the day of the HCG prescription in both groups by one of the two attending physicians. Chemical pregnancy will be detected by serum beta-hCG analysis 14 days after embryo transfer and transvaginal ultrasound scan will be scheduled 2 weeks later to confirm the diagnosis of clinical pregnancy. The intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.
Masking: Single (Participant)
Masking Description: Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes
Primary Purpose: Supportive Care
Official Title: Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI: A Randomized Clinical Trial
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : September 1, 2018
Estimated Study Completion Date : September 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group
intervention group will receive pentoxifylline (Trental S.R.) 400 mg/BD plus vit E (PHARCO) 400 mg/BD 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled.
Drug: pentoxifylline
will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled
Other Name: Trental S.R. 400 mg/BD

Drug: Vit E
will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled
Other Name: Vit E PHARCO 400 mg/BD

No Intervention: comparison group
. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.



Primary Outcome Measures :
  1. clinical pregnancy rate. [ Time Frame: two weeks after embryo transfer ]
    serum beta-hCG analysis 14 days after embryo transfer

  2. clinical pregnancy rate [ Time Frame: two weeks after embryo transfer ]
    transvaginal ultrasound scan will be scheduled 2 weeks after embryo transfer to confirm the diagnosis of clinical pregnancy



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   female patients according to physical appearance and sex accepted socially
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • infertile female patients under 39 years

Exclusion Criteria:

  • hypothalamic amenorrhea
  • drug reactions or complications
  • endometrioses
  • fibroids

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): NCT03476564


Contacts
Contact: ahmed amr fayez, M.B.B.CH (002)01066653186 ahmed_fayez275@yahoo.com

Locations
Egypt
El Galaa Teaching hosptial Recruiting
Cairo, Ghamra, Egypt
Sponsors and Collaborators
Benha University
El Galaa Teaching Hospital
Benha University Hospital

Responsible Party: Ahmed Amr Fayez, doctor, Benha University
ClinicalTrials.gov Identifier: NCT03476564     History of Changes
Other Study ID Numbers: BenhaU1
First Posted: March 26, 2018    Key Record Dates
Last Update Posted: March 26, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ahmed Amr Fayez, Benha University:
assisted reproductive techniques

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Female
Genital Diseases, Male
Vitamin E
Pentoxifylline
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Vitamins
Micronutrients
Growth Substances
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Platelet Aggregation Inhibitors
Radiation-Protective Agents
Vasodilator Agents
Free Radical Scavengers