MIP: Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome

• Sponsor: Ain Shams University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02498522
• Collaborator: (none)
• Enrollment: 166
• Location: 1
• Arms: 2
• Duration (Months): 7
• Patients Per Site Per Month: 23.7

Study Details

Study Description

Brief Summary

The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Drug: Metformin	Early Phase 1

Detailed Description

Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility

• The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS

• Research question:

In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?

-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.

Study Design

• Study Type: Interventional
• Actual Enrollment: 166 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
• Study Start Date: Aug 1, 2015
• Actual Primary Completion Date: Feb 1, 2016
• Actual Study Completion Date: Mar 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: metformin arm 83 patients will continue metformin until end of 1st trimester (14 weeks gestation)	Drug: Metformin; 83 patients will continue metformin until end of 1st trimester; Other Names: cidophage
Placebo Comparator: control arm 83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)	Drug: Metformin; 83 patients will continue metformin until end of 1st trimester; Other Names: cidophage

Outcome Measures

Primary Outcome Measures

1. Miscarriage Rate [6 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age : 25 - 35.

• Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )

• At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.

• Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.

• Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.

• Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.

Exclusion Criteria:

• patients with other causes of infertility other than PCOS

• contraindications to metformin : liver impairment , renal failure.

• Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Medicine, Ain Shams University	Cairo	Al Qahirah	Egypt

Sponsors and Collaborators

• Ain Shams University

Investigators

• Principal Investigator: Ahmed M kotb, MD, Ain Shams University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Islam Dabbous, doctor, Ain Shams University
• ClinicalTrials.gov Identifier: NCT02498522
• Other Study ID Numbers: Metformin in pregnancy
• First Posted: Jul 15, 2015
• Last Update Posted: May 19, 2016
• Last Verified: Apr 1, 2016

• Additional relevant MeSH terms: Polycystic Ovary Syndrome; Abortion, Spontaneous; Syndrome; Metformin

Study Results

Participant Flow

Arm/Group Title	Metformin Arm	Control Arm
Arm/Group Description	83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester
Period Title: Overall Study
STARTED	85	85
COMPLETED	83	83
NOT COMPLETED	2	2

Baseline Characteristics

Arm/Group Title	Metformin Arm	Control Arm	Total
Arm/Group Description	83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	Total of all reporting groups
Overall Participants	83	83	166
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	83 100%	83 100%	166 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.2 (1.6)	30.1 (1.9)	30.1 (1.7)
Sex: Female, Male (Count of Participants)
Female	83 100%	83 100%	166 100%
Male	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
Egypt	83 100%	83 100%	166 100%

Outcome Measures

1. Primary Outcome

Title	Miscarriage Rate
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Metformin Arm	Control Arm
Arm/Group Description	83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester	83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester
Measure Participants	83	83
Number (95% Confidence Interval) [participants]	9 10.8%	35 42.2%

Adverse Events

Arm/Group Title	Metformin Arm		Control Arm
Arm/Group Description	83 patients will continue metformin until end of 1st trimester (14 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester		83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation) Metformin: 83 patients will continue metformin until end of 1st trimester
All Cause Mortality
	Metformin Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Metformin Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/83 (0%)
Other (Not Including Serious) Adverse Events
	Metformin Arm		Control Arm
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	16/83 (19.3%)		6/83 (7.2%)
Gastrointestinal disorders
vomiting	16/83 (19.3%)	16	6/83 (7.2%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.