ClinicalTrials.gg
Status unknownNCT02186782Updated Mar 22, 2017

Concomitant CC and E2 Versus CC Alone in Ovulation Induction

A Phase 4 interventional study of Clomiphene citrate and Estradiol and Clomiphene citrate and Placebo in Infertility and Anovulation, sponsored by Maher elesawi kamel elesawi. Status unknown at 3 sites in Egypt. Open to female participants aged 20 Years to 39 Years. Per ClinicalTrials.gov, last updated 2017-03-22.

Sponsored by Maher elesawi kamel elesawi · Phase 4, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2017), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 4
Study type
Interventional
Enrollment
600
Allocation
Randomized
Ages
20 Years to 39 Years
Sex
Female
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 33 studies testing clomiphene in Infertility — 1 open to participants now, 4 under way, 1 of them phase 3. Clomiphene · Infertility.

Planned enrollment
4th of 33
600 · median 154
Started
2014
with 1 other
Phase 4
19 of 33
1 open now
Registered
19th of 33
by date

Among the 33 studies testing clomiphene in Infertility, this one is the 4th largest by planned enrollment, is one of 2 that started in 2014, is one of 19 in phase 4, and was the 19th registered.

By phase

33 studies; the count open now beside each. This study's row is marked.

Phase 4this study19 · 1 open
No phase7 · 0 open
Phase 35 · 0 open
Phase 1/21 · 0 open
Phase 2/31 · 0 open

By the year they started

First in 1991; this study’s year is marked. 2 started in 2014.

Size and results

Median enrollment 154 across the 33 interventional studies. Of the 18 that completed or were terminated, 6 (33%) have results posted.

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02

Study summary

The purpose of this study is to evaluate the effect of concomitant administration of estradiol during use of clomiphene citrate (CC) for induction of ovulation in infertile women.

Read the detailed description

Women will be randomly divided into two groups; CC-E2 group and CC group. Women in the CC-E2 group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle). Women in the CC group will receive CC (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo mimic estradiol (for 5 consecutive days from day 2 of cycle). Transvaginal sonography (TVS) scan will be performed regularly for monitoring of follicular growth (folliculometry); starting from day 10 of the stimulation cycle and repeated every 2-3 days. When there will be at least one follicle ≥ 18 mm in diameter, final oocyte maturation will be induced by intramuscular administration of 10000 IU of human chorionic gonadotropin (HCG) and timed intercourse will be advised. If there will be no follicle ≥ 12 mm by day 16 of the cycle, monitoring of follicular growth will be discontinued and the cycle will be presumed to be anovulatory. Ovulation will be documented by TVS scan one week after triggering of oocyte maturation and will be confirmed by assessing the midluteal serum progesterone level. Each woman will be subjected to ovarian stimulation for a maximum of 3 consecutive cycles except if she gets pregnant in the first or second cycle.

03

Conditions studied

  • Infertility
  • Anovulation

Keywords

  • Clomiphene citrate
  • Estradiol
  • Endometrial thickness
04

Who can participate

Ages eligible
20 Years to 39 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Infertile women with eugonadotrophic anovulation/oligoovulation.
  • Unexplained infertility.

Exclusion criteria

Exclusion Criteria:

  • Age \< 20 or > 35 years.
  • (BMI) \< 18.5 kg/m2 or > 25 kg/m2.
  • Presence of any infertility factor other than anovulation/oligoovulation.
  • Previous history of ovarian surgery or surgical removal of one ovary.
  • Previous exposure to cytotoxic drugs or pelvic irradiation.
  • Metabolic or hormonal abnormalities.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
600 participants (estimated)

Study arms

  • Active comparator
    Clomiphene citrate-Estradiol group

    Women will receive clomiphene citrate and estradiol

    Drug: Clomiphene citrate and Estradiol

  • Active comparator
    Clomiphene citrate group

    Women will receive clomiphene citrate and placebo

    Drug: Clomiphene citrate and Placebo

Interventions

  • DrugClomiphene citrate and Estradiol

    Drug pages: Clomiphene · Estradiol

    Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)

    Also known as: Clomid and Estradiol valerate

  • DrugClomiphene citrate and Placebo

    Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)

    Also known as: Clomid and Placebo

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rate

    Number of clinical pregnancies (defined as presence of at least one intrauterine gestational sac with fetal pole and cardiac activity on TVS scan at 6-8 weeks gestational age) divided by the number of women

    Time frame: 6-8 weeks gestational age

Secondary outcomes

  1. Endometrial thickness on day of HCG administration

    Endometrial thickness by TVS on day of HCG administration

    Time frame: 3 months

Other outcomes

  1. Ovulation rate

    Number of ovulatory cycles divided by the number of stimulation cycles

    Time frame: 3 months

  2. Number of ovarian follicles ≥ 18 mm on day of HCG administration

    Number of ovarian follicles ≥ 18 mm by TVS on day of HCG administration

    Time frame: 3 months

07

Study locations

3 of 3 sites recruiting
  • Obstetrics and Gynecology Department in Mansoura University Hospital
    Mansoura, Dakahlia 35111, Egypt
    Recruiting
  • Private practice settings
    Mansoura, Dakahlia, Egypt
    Recruiting
    • Ahmed M Badawy, Prof · Contactambadawy@yahoo.com · +201282848485
    • Ahmed M Badaway, Prof · Principal investigator
  • Private practice settings
    Mit Ghamr, Dakahlia, Egypt
    Recruiting
    • Maher E Kamel Elesawi, Dr · Contactmaherelesawi@yahoo.com · +20104523494
    • Maher E Kamel Elesawi, Dr · Principal investigator
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2014, a primary completion of Jul 2018 and a completion of Aug 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 28, 2014
First posted
Jul 10, 2014
Start
Jun 2014
Primary completionEst.
Jul 2018
CompletionEst.
Aug 2018
Last update
Mar 22, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 22, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02186782
Lead sponsor
Maher elesawi kamel elesawi
Responsible party
Maher elesawi kamel elesawi (Dr, Mansoura University) — Sponsor-investigator
First posted
Jul 10, 2014
Start date
Jun 2014
Primary completion
Jul 2018 (estimated)
Completion
Aug 2018 (estimated)
Last update
Mar 22, 2017

Study contacts

Maher E Kamel Elesawi, Dr
Contact
maherelesawi@yahoo.com
+201016103662
Ahmed M Badawy, Prof
Contact
ambadawy@yahoo.com
+201282848485
Ahmed M Badawy, Prof
principal investigator · Mansoura University
Maher E Kamel Elesawi, Dr
study director · Mansoura University
Mohamed S Abdelhafez, Dr
study director · Mansoura University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Clomiphene · Estradiol

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