Endometrial ThicknessNCT04619914
the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women
A study testing Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt and letrozole (Femara; Novartis pharma AG, Basle, Switzerland) in people with Endometrial Thickness and Pregnancy Rate, run by Laylay Mohammed Khalleefah Alhibshi at 1 site in Egypt.
Trial summary
The present randomized double blind study has been carried out in Gynecology and Obstetrics Department, Faculty of Medicine, Zagazig university on 70 women were previously received clomiphene citrate alone as management of infertile anovulatory PCOS women, but giving improper endometrial thickness < 7mm during the… Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Endometrial Thickness, Pregnancy Rate
- What is being tested?
- Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt and letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 10 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- patients aged 18-35 years old with complete infertility workup
- patients diagnosed as having PCOs women
- Normal semen analysis
Who cannot join
- Patients with male factor infertility, hyperprolactinemia, thyroid disorder.
- Patients with any tubal pathology or uterine pathology.
- Contraindication of ovulation induction, (Multiple ovarian cysts or allergy to inducing agent "clomid").
- Known or suspected pelvic infection (PID).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women With Polycystic Ovarian Syndrome
The present randomized double blind study has been carried out in Gynecology and Obstetrics Department, Faculty of Medicine, Zagazig university on 70 women were previously received clomiphene citrate alone as management of infertile anovulatory PCOS women, but giving improper endometrial thickness < 7mm during the period from March 2019 to September 2019
Read the detailed description
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in infertile women. Infertility affects 40% of women with PCOS. Understanding the main causes of infertility and selecting an appropriate treatment plan is a diagnostic and therapeutic priority The aim of this work was to compare the effect of Clomiphene citrate plus Estradiol Valerate versus Letrozole on endometrial thickness and pregnancy rate in infertile PCOS women underwent ovulation induction
The study was designed as a randomized double blind study using a computer-generated randomization list and sequentially numbered opaque sealed envelopes, each containing the allocation information written on a card. Envelopes were opened sequentially by a study nurse to allocate patients to the assigned group. These patients were divided into two groups:
- Group A (clomiphene citrate \& estradiol group): included 35 anovulatory PCO patients who received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white tablets of cyclopregynova) from cycle day 8 to 14.
- Group B (Letrozole group): included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.
- Conditions
- Endometrial Thickness, Pregnancy Rate
- Being tested
- Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt, letrozole (Femara; Novartis pharma AG, Basle, Switzerland)
- Keywords
- Letrozole, clomiphene Citrate, PCOS, Endometrial thickness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, EgyptDrug
CLOMID (clomiphene citrate tablets USP) is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1)
letrozole (Femara; Novartis pharma AG, Basle, Switzerland)Drug
Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine.
| Study group | Role | What they receive |
|---|---|---|
| Group A (clomiphene citrate & estradiol group) | Experimental | included 35 anovulatory PCO patients who received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white tablets of cyclopregynova) from cycle day 8 to 14 Receives: Drug: Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt |
| Group B (Letrozole group) | Experimental | included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7. Receives: Drug: letrozole (Femara; Novartis pharma AG, Basle, Switzerland) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the endometrial thickness
Thickness was measured by placing electronic calipers on the outer walls of the endometrium at its widest diameter as seen in the longitudinal axis of the uterine body
Measured: up to 24 weeks
Secondary outcomes (1)
the ovulation rate
The number of follicles that mature and ovulate during a given menstrual or estrous cycle is referred to as ovulation rate or quota.
Measured: up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2020
- Study start1 Mar 2019
- Primary completion1 Jul 2019
- Study completion10 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial ThicknessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laylay Mohammed Khalleefah Alhibshi
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Laylay Mohammed Khalleefah Alhibshi, Zagazig University
- Investigators
- Abdel-Mageed M Sarhan, MD, Study director, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04619914
- Sponsor's protocol ID
- ZU-IRB# 5057/19-12-2018
- Status last verified
- Nov 2020
- First submitted
- 2 Nov 2020
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effect of Clomiphene Citrate Plus Estradiol Valerate Versus Letrozole on Endometrial Thickness and Pregnancy Rate in Infertile Women With Polycystic Ovarian Syndrome
- ClinicalTrials.gov ID
- NCT04619914
- Acronym / sponsor ID
- ZU-IRB# 5057/19-12-2018
- Conditions
- Endometrial Thickness, Pregnancy Rate
- Keywords
- Letrozole, clomiphene Citrate, PCOS, Endometrial thickness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Laylay Mohammed Khalleefah AlhibshiOther government
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Jul 2019 (actual)
- Study completion
- 10 Aug 2019 (actual)
- First posted
- 6 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present randomized double blind study has been carried out in Gynecology and Obstetrics Department, Faculty of Medicine, Zagazig university on 70 women were previously received clomiphene citrate alone as management of infertile anovulatory PCOS women, but giving improper endometrial thickness < 7mm during the period from March 2019 to September 2019
Detailed description
Polycystic Ovarian Syndrome (PCOS) is the most common endocrine disorder in infertile women. Infertility affects 40% of women with PCOS. Understanding the main causes of infertility and selecting an appropriate treatment plan is a diagnostic and therapeutic priority The aim of this work was to compare the effect of Clomiphene citrate plus Estradiol Valerate versus Letrozole on endometrial thickness and pregnancy rate in infertile PCOS women underwent ovulation induction
The study was designed as a randomized double blind study using a computer-generated randomization list and sequentially numbered opaque sealed envelopes, each containing the allocation information written on a card. Envelopes were opened sequentially by a study nurse to allocate patients to the assigned group. These patients were divided into two groups:
- Group A (clomiphene citrate \& estradiol group): included 35 anovulatory PCO patients who received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white tablets of cyclopregynova) from cycle day 8 to 14.
- Group B (Letrozole group): included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A (clomiphene citrate & estradiol group) | Experimental | Drug: Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egyptincluded 35 anovulatory PCO patients who received clomiphene citrate (Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg daily from cycle day 3 to 7 with estradiol valerate 4-mg (two white tablets of cyclopregynova) from cycle day 8 to 14 |
| Group B (Letrozole group) | Experimental | Drug: letrozole (Femara; Novartis pharma AG, Basle, Switzerland)included 35 anovulatory PCO patients who received letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 5 mg daily from cycle day 3 to day 7. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients aged 18-35 years old with complete infertility workup
- patients diagnosed as having PCOs women
- Normal semen analysis
Key exclusion criteria (4 listed)
- Patients with male factor infertility, hyperprolactinemia, thyroid disorder.
- Patients with any tubal pathology or uterine pathology.
- Contraindication of ovulation induction, (Multiple ovarian cysts or allergy to inducing agent "clomid").
- Known or suspected pelvic infection (PID).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, EgyptCLOMID (clomiphene citrate tablets USP) is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1) | Drug | Group A (clomiphene citrate & estradiol group) |
| letrozole (Femara; Novartis pharma AG, Basle, Switzerland)Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine. | Drug | Group B (Letrozole group) |
Primary outcome
the endometrial thickness
Time frame: up to 24 weeks
Thickness was measured by placing electronic calipers on the outer walls of the endometrium at its widest diameter as seen in the longitudinal axis of the uterine body
1 secondary outcome
the ovulation rate
Time frame: up to 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdel-Mageed M Sarhan, MD study director
Zagazig University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt and letrozole (Femara; Novartis pharma AG, Basle, Switzerland) in people with Endometrial Thickness and Pregnancy Rate, run by Laylay Mohammed Khalleefah Alhibshi at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the endometrial thickness (time frame: up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2020.