Trial Outcomes & Findings for Sildenafil Vaginal Gel Co-treatment With Clomiphene Citrate in Infertile Women With Thin Endometrium (NCT NCT02710981)
NCT ID: NCT02710981
Last Updated: 2020-05-05
Results Overview
Transvaginal sonographic measurement of maximal distance spanning endometrial- myometrial interphase on each endometrial stripe in a sagittal plane in the fundus of the uterus
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
42 participants
Primary outcome timeframe
Day of HCG administration
Results posted on
2020-05-05
Participant Flow
As this is a self controlled clinical trial, participants in the clomiphene citrate only arm (6th ovulation induction cycle) are the same participant in the clomiphene citrate plus sildenafil vaginal gel arm (7th ovulation induction cycle).
Participant milestones
| Measure |
Clomiphene Citrate Only
Clomiphene citrate only arm: Patients underwent 6th ovulation induction cycle in which women received Clomiphene citrate (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days). A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection). Period of this arm is one menstrual cycle (6th induction cycle)
|
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)
Clomiphene citrate plus sildenafil vaginal gel arm: Women who did not conceive on the 6th cycle ( clomiphene citrate only cycle; 41 women) were offered a 7th cycle in which they were given Clomiphene citrate 100 mg/ day starting from day of the cycle for 5 days, with adding sildenafil vaginal gel 5 gm twice daily starting from cycle day 8 on until day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection). Period of this arm is the subsequent menstrual cycle (7th induction cycle)
|
|---|---|---|
|
6th Ovulation Induction Cycle (5 Days)
STARTED
|
42
|
0
|
|
6th Ovulation Induction Cycle (5 Days)
COMPLETED
|
41
|
0
|
|
6th Ovulation Induction Cycle (5 Days)
NOT COMPLETED
|
1
|
0
|
|
7th Ovulation Induction Cycle (5 Days)
STARTED
|
0
|
41
|
|
7th Ovulation Induction Cycle (5 Days)
COMPLETED
|
0
|
36
|
|
7th Ovulation Induction Cycle (5 Days)
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)
n=41 Participants
Infertile women who have completed 5 cycles of clomiphene citrate with successful ovulation, thin endometrium and no pregnancy who are attempting a 6th cycle of clomiphene citrate.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=41 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=41 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=41 Participants
|
|
Age, Continuous
|
26.8 years
STANDARD_DEVIATION 2.8 • n=41 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=41 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=41 Participants
|
|
Region of Enrollment
Egypt
|
41 participants
n=41 Participants
|
|
Serum FSH
|
4.5 U/L
STANDARD_DEVIATION 1.5 • n=41 Participants
|
PRIMARY outcome
Timeframe: Day of HCG administrationTransvaginal sonographic measurement of maximal distance spanning endometrial- myometrial interphase on each endometrial stripe in a sagittal plane in the fundus of the uterus
Outcome measures
| Measure |
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)
n=41 Participants
Infertile women who had undergone 5 cycles of clomiphene citrate ovulation induction with ovulation detected, and no pregnancy due to thin endometrium
|
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)
n=36 Participants
Women who did not get pregnant after 6th ovulation induction cycle receive a 7th induction cycle with clomiphene citrate plus sildenafil vaginal gel
|
|---|---|---|
|
Endometrial Thickness
|
6.6 millimeter
Standard Deviation 1.4
|
9.3 millimeter
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: Day of HCG administrationDoppler ultrasound is used to measure the pulsatility index in both uterine arteries. Pulsatility index is a measure of the arterial resistance to blood flow. The higher the value of the pulsatility index, the more resistant the uterine arteries are, and hence the worst the outcome.
Outcome measures
| Measure |
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)
n=41 Participants
Infertile women who had undergone 5 cycles of clomiphene citrate ovulation induction with ovulation detected, and no pregnancy due to thin endometrium
|
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)
n=36 Participants
Women who did not get pregnant after 6th ovulation induction cycle receive a 7th induction cycle with clomiphene citrate plus sildenafil vaginal gel
|
|---|---|---|
|
Uterine Blood Flow
|
2.4 index
Standard Deviation 0.8
|
1.6 index
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: At the end of a 28-day menstrual cycle.Identifying pregnancy through positive urinary HCG test plus sonographic detection of cardiac pulsations
Outcome measures
| Measure |
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)
n=41 Participants
Infertile women who had undergone 5 cycles of clomiphene citrate ovulation induction with ovulation detected, and no pregnancy due to thin endometrium
|
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)
n=36 Participants
Women who did not get pregnant after 6th ovulation induction cycle receive a 7th induction cycle with clomiphene citrate plus sildenafil vaginal gel
|
|---|---|---|
|
Clinical Pregnancy Rate
|
0 Participants
|
3 Participants
|
Adverse Events
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Clomiphene Citrate Only Group (6th Ovulation Induction Cycle)
n=41 participants at risk；n=42 participants at risk
Infertile women who had undergone 5 cycles of clomiphene citrate ovulation induction with ovulation detected, and no pregnancy due to thin endometrium (N =41)
|
Clomiphene Citrate Plus Sildenafil Vaginal Gel (7th Ovulation)
n=36 participants at risk；n=41 participants at risk
Women who did not get pregnant after 6th ovulation induction cycle receive a 7th induction cycle with clomiphene citrate plus sildenafil vaginal gel
|
|---|---|---|
|
Vascular disorders
Vasodilatory headache
|
0.00%
0/41
|
2.8%
1/36 • Number of events 1
|
Additional Information
Essam R. Othman
OB-GYN department, Assiut University, Egypt
Phone: +201006607801
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place