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Adding Prostaglandin to Clomiphene Citrate in Mild Ovarian Stimulation Protocol in those Undergoing Intrauterine Insemination; A Randomized, Double-Blind, Clinical Trial

Protocol summary

Study aim
To determine the effects of adding prostaglandin to CC in mild ovarian stimulation protocol on pregnancy and implantation rate in patients undergoing intrauterine insemination (IUI).
Design
In this randomized, double-blind, placebo-controlled study, we will include a total number of 106 patients who will be randomized to two study groups each containing 53 patients. This is a phase 3 trial.
Settings and conduct
The study will be conducted Shiraz Ghadir Mother and Child hospital, affiliated with Shiraz University of Medical Sciences. Patients will be randomly assigned to received mild ovarian stimulation with clomiphene citrate, gonadotropins and misoprostol (intervention group) and mild ovarian stimulation with clomiphene citrate, gonadotropins and placebo (control group). All the interventionists, those recording the outcome measures and patients will be blinded to the study groups.
Participants/Inclusion and exclusion criteria
All the patients who are candidates and refer to the Shiraz Ghadir mother and child hospital will be included in the study. All the participants must be between 18 and 45 years of age. Those with hypersensitivity to prostaglandins, polycystic ovarian syndrome (PCOS) and those with history of hepatic and renal disorders will be eliminated from the study.
Intervention groups
Study groups include mild ovarian stimulation with clomiphene citrate, gonadotropins and misoprostol (intervention group) and mild ovarian stimulation with clomiphene citrate, gonadotropins and placebo (control group).
Main outcome variables
Implantation rate, number and size of dominant ovarian follicles, endometrial thickness, pregnancy rate, side effects.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20090912002445N8
Registration date: 2019-07-31, 1398/05/09
Registration timing: retrospective

Last update: 2019-07-31, 1398/05/09
Update count: 0
Registration date
2019-07-31, 1398/05/09
Registrant information
Name
Fariborz Ghaffarpasand
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4259
Email address
ghafarf@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
2018-05-22, 1397/03/01
Actual recruitment end date
2019-02-20, 1397/12/01
Trial completion date
2019-02-20, 1397/12/01
Scientific title
Adding Prostaglandin to Clomiphene Citrate in Mild Ovarian Stimulation Protocol in those Undergoing Intrauterine Insemination; A Randomized, Double-Blind, Clinical Trial
Public title
Effects of prostaglandin and clomiphene citrate on pregnancy outcome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with primary and secondary infertility Age between 18 and 45 years Candidates for mild ovarian stimulation and intrauterine insemination (IUI)
Exclusion criteria:
Sensitivity to prostaglandins Medical history of hepatic or renal diseases Polycystic ovarian syndrome (PCOS) Not having consent for inclusion in the study
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 106
Actual sample size reached: 106
Randomization (investigator's opinion)
Randomized
Randomization description
All the patients will be randomized into two study groups using a computer-based random digit generator utilizing the patients; registration numbers.
Blinding (investigator's opinion)
Double blinded
Blinding description
Medications and placebo will be prepared in the same capsules. Those giving the intervention, the patients, those recording the study outcomes will be blinded to the study groups. Only the statisticians will know the study groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics committee office, 7th Floor, Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
794-01-50-105871345-
Approval date
2016-02-12, 1394/11/23
Ethics committee reference number
IR.SUMS.MED.REC.94.01.50.10587

Health conditions studied

1

Description of health condition studied
Infertility
ICD-10 code
N97.4
ICD-10 code description
Female infertility associated with male factors

Primary outcomes

1

Description
Pregnancy Rate
Timepoint
14 weeks
Method of measurement
Chemical Beta-HCG test

Secondary outcomes

1

Description
Number of Dominant Follicle
Timepoint
14 days
Method of measurement
Transvaginal Sonography

2

Description
Endometrial thinkness
Timepoint
14 days
Method of measurement
Transvaginal sonography

3

Description
Side effects
Timepoint
1 month
Method of measurement
Adverse effects form

Intervention groups

1

Description
Intervention group: Clomiphene citrate (100mg daily from day 5 to 9 of menstrual cycle), gonadotropin (75 IU subcutaneously from day 8 to 11 of menstrual cycle), misoprostol (100mg twice daily from day 5 to 9 of menstrual cycle).
Category
Treatment - Drugs

2

Description
Control group: lomiphene citrate (100mg daily from day 5 to 9 of menstrual cycle), gonadotropin (75 IU subcutaneously from day 8 to 11 of menstrual cycle), placebo (1 capsule twice daily from day 5 to 9 of menstrual cycle).
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Ghadir Mother and Child Hospital
Full name of responsible person
Afsoon Zarei
Street address
Ghadir Mother and Child hospital, Emam Reza Ave.,
City
Shiraz
Province
Fars
Postal code
7173646199
Phone
+98 71 3227 9701
Fax
+98 71 3227 9701
Email
zareia@sums.ac.ir
Web page address
http://shirazmch.ir/en/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Floor No. 7, Shiraz University of Medical Sciences, Zand Avenue
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 71 3235 7282
Fax
+98 71 3212 2430
Email
vcrdep@sums.ac.ir
Web page address
http://research.sums.ac.ir/fa/index.html
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Keramati
Position
Fellowship resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghadir Mother and Child Hospital, Emam Reza Ave.
City
Shiraz
Province
Fars
Postal code
7173646199
Phone
+98 71 3227 9701
Fax
+98 71 3227 9701
Email
keramati@hotmail.com
Web page address
http://shirazmch.ir/en/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Afsoon Zarei
Position
Assistant Professor
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghadir Mother and Child Hospital, Emam Reza Ave.
City
Shiraz
Province
Fars
Postal code
7173646199
Phone
+98 71332279701
Email
zareia@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Pegah Keramari
Position
Fellowship Resident
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Ghadir Mother and Child hospital, Emam Reza Ave,
City
Shiraz
Province
Fars
Postal code
7173646199
Phone
+98 71 3227 9701
Fax
+98 71 3227 9701
Email
pegah-keramati@hotmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The baseline, clinical, and outcome measures databases would be available in SPSS format after publication of the study.
When the data will become available and for how long
The data will be available immediately after publication of the study.
To whom data/document is available
The data would be to the readers of the published article through the journal's policy and website.
Under which criteria data/document could be used
The is not limitation for accessing the study data after publication.
From where data/document is obtainable
The database would be available as an appendix to the published article.
What processes are involved for a request to access data/document
The database would be available as an appendix to the published article. The availability would be according to the publisher's policy.
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