Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:
Primary Purpose
Infertility, Female
Status
Unknown status
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
pentoxifylline
Vit E
Sponsored by
About this trial
This is an interventional supportive care trial for Infertility, Female focused on measuring assisted reproductive techniques
Eligibility Criteria
Inclusion Criteria:
- infertile female patients under 39 years
Exclusion Criteria:
- hypothalamic amenorrhea
- drug reactions or complications
- endometrioses
- fibroids
Sites / Locations
- El Galaa Teaching hosptial
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
comparison group
Arm Description
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.
Outcomes
Primary Outcome Measures
clinical pregnancy rate.
serum beta-hCG analysis 14 days after embryo transfer
clinical pregnancy rate
transvaginal ultrasound scan will be scheduled 2 weeks after embryo transfer to confirm the diagnosis of clinical pregnancy
Secondary Outcome Measures
Full Information
NCT ID
NCT03476564
First Posted
March 2, 2018
Last Updated
March 18, 2018
Sponsor
Benha University
Collaborators
El Galaa Teaching Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03476564
Brief Title
Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:
Official Title
Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI: A Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2018 (Anticipated)
Primary Completion Date
September 1, 2018 (Anticipated)
Study Completion Date
September 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University
Collaborators
El Galaa Teaching Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
Our findings will provide preliminary clinical evidence to suggest the new experimental treatment approaches, toward female factor infertility treatment with pentoxyfylline.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Female
Keywords
assisted reproductive techniques
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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
Participant
Masking Description
Computer generated random number table will be used for randomization. Group assignments will be placed in sealed opaque sequentially numbered envelopes
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
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.
Arm Title
comparison group
Arm Type
No Intervention
Arm Description
. The comparison group will not receive the above drugs. The main outcome measure will be clinical pregnancy rate.
Intervention Type
Drug
Intervention Name(s)
pentoxifylline
Other Intervention Name(s)
Trental S.R. 400 mg/BD
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Vit E
Other Intervention Name(s)
Vit E PHARCO 400 mg/BD
Intervention Description
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
Primary Outcome Measure Information:
Title
clinical pregnancy rate.
Description
serum beta-hCG analysis 14 days after embryo transfer
Time Frame
two weeks after embryo transfer
Title
clinical pregnancy rate
Description
transvaginal ultrasound scan will be scheduled 2 weeks after embryo transfer to confirm the diagnosis of clinical pregnancy
Time Frame
two weeks after embryo transfer
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
female patients according to physical appearance and sex accepted socially
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
infertile female patients under 39 years
Exclusion Criteria:
hypothalamic amenorrhea
drug reactions or complications
endometrioses
fibroids
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ahmed amr fayez, M.B.B.CH
Phone
(002)01066653186
Email
ahmed_fayez275@yahoo.com
Facility Information:
Facility Name
El Galaa Teaching hosptial
City
Cairo
State/Province
Ghamra
Country
Egypt
12. IPD Sharing Statement
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Effects of Pentoxifylline and Vitamin E on Pregnancy Rate in Infertile Women Treated by ICSI:
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