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Trial record 3 of 9 for:    effects of progesterone on lh AND pcos AND CONTROLS

Ovulation Induction in Women With Clomiphene Citrate Resistant PCOS

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ghada Abdel Fattah, Cairo University
ClinicalTrials.gov Identifier:
NCT01909141
First received: July 15, 2013
Last updated: February 19, 2015
Last verified: February 2015
  Purpose

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the American College of Obstetrics and Gynecology (ACOG) recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC may be associated with poor endometrial thickening due to its antiestrogenic effect. Letrozole may improve this condition. In this study we will compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.


Condition Intervention Phase
Polycystic Ovary Syndrome
Infertility
Drug: induction of ovulation using letrozole-pioglitazone-metformin
Drug: induction of ovulation using clomiphene citrate-pioglitazone-metformin
Radiation: transvaginal ultrasound
Other: body mass index (BMI) calculation
Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone
Other: pretreatment blood urea and serum creatinine
Other: serum estradiol (E2) on day 12
Other: serum progesterone on day 21
Other: blood urea and serum creatinine every month
Phase 0

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Combined Letrozole-metformin-pioglitazone Versus Combined Clomiphene Citrate-metformin-pioglitazone in Clomiphene Citrate-resistant Women With Polycystic Ovary Syndrome

Resource links provided by NLM:


Further study details as provided by Cairo University:

Primary Outcome Measures:
  • Ovulation Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of Follicles>18mm. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Endometrial Thickness [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Pregnancy Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Safety of Pioglitazone as Regards Serum Creatinine [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    serum creatinine was measured at the end of the study period (after 3 months) in both groups.


Enrollment: 100
Study Start Date: August 2013
Study Completion Date: April 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: arm 1:letrozole-pioglitazone -metformin group
Arm 1 will receive letrozole 2.5 mg/day starting from the 3rd day of the cycle and for 5 days and (combined pioglitazone 15 mg+ metformin 850 mg) once daily from the first day of the cycle for 10 days.
Drug: induction of ovulation using letrozole-pioglitazone-metformin
induction of ovulation will be done for arm 1 for 3 consecutive cycles unless pregnancy occured.
Radiation: transvaginal ultrasound
transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
Other: body mass index (BMI) calculation
BMI will be calculated for all women by dividing the weight in kilograms by the height in meters squared
Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone
baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) will be done for all women.
Other: pretreatment blood urea and serum creatinine
blood urea and serum creatinine will be assayed before stating induction of ovulation to have baseline levels.
Other: serum estradiol (E2) on day 12
serum E2 will be assayed on day 12 of the cycle for all women.
Other: serum progesterone on day 21
serum progesterone will be assayed on day 21 for all women to monitor ovulation.
Other: blood urea and serum creatinine every month
blood urea and serum creatinine will be assayed every month during the treatment period to find out any hazards on kidney functions
Active Comparator: arm 2: clomiphene citrate-pioglitazone-metformin
Arm 2 will receive clomiphene citrate 100 mg/day starting from the 3rd day of the cycle for 5 days and (combined pioglitazone 15 mg + metformin 850 mg) once daily from the first day of the cycle for 10 days.
Drug: induction of ovulation using clomiphene citrate-pioglitazone-metformin
induction of ovulation for arm 2 will be done in 3 consecutive cycles unless pregnancy occured.
Radiation: transvaginal ultrasound
transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
Other: body mass index (BMI) calculation
BMI will be calculated for all women by dividing the weight in kilograms by the height in meters squared
Other: day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone
baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) will be done for all women.
Other: pretreatment blood urea and serum creatinine
blood urea and serum creatinine will be assayed before stating induction of ovulation to have baseline levels.
Other: serum estradiol (E2) on day 12
serum E2 will be assayed on day 12 of the cycle for all women.
Other: serum progesterone on day 21
serum progesterone will be assayed on day 21 for all women to monitor ovulation.
Other: blood urea and serum creatinine every month
blood urea and serum creatinine will be assayed every month during the treatment period to find out any hazards on kidney functions

Detailed Description:

Polycystic ovary syndrome (PCOS) affects 5-10% of women in childbearing age. Hyperinsulinemia contributes to chronic anovulation commonly encountered in women with PCOS. The first choice therapy is clomiphene citrate (CC). In CC resistant cases, the ACOG recommends the use of insulin sensitizer metformin. Other insulin sensitizing agents include rosiglitazone and pioglitazone. Pioglitazone is said to improve fertility and ovulation in patients with PCOS.CC has a long half-life (2 weeks), and this may have a negative effect on the cervical mucus and endometrium, leading to discrepancy between ovulation and conception rates. There has been a search for a compound capable of inducing ovulation but devoid of the adverse antiestrogenic effects of CC. recent studies have suggested that letrozole, an aromatase inhibitor, does not possess the adverse antiestrogenic effects of CC and is associated with higher pregnancy rates than CC treatment in patients with PCOS.

In this study we shall compare the effect of combined letrozole-metformin-pioglitazone with that of combined CC-metformin-pioglitazone in ovulation induction in CC-resistant PCOS women.This will be a prospective comparative clinical trial in which 2 groups of women will be generated (groups A and B) using the sealed envelopes randomization method.Group A (40 women) will receive: letrozole 2.5 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Group B (40 women) will receive clomiphene citrate 100 mg/day from 3rd day of the cycle for 5 days and (pioglitazone 15 mg + metformin 850 mg) once daily from 1st day of the cycle for 10 days. Ovulation will be monitored by vaginal ultrasound and serum estrogen and progesterone.

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 20-40 years old
  • PCOS infertile women resistant to CC for3 cycles

Exclusion Criteria:

  • presence of medical disorders as diabetes, hypertension, cardiac problems, liver or kidney diseases, hyperprolactinemia or thyroid dysfunction.
  • use of gonadotropins before
  • previous ovarian drilling
  • presence of urinary symptoms especially bloody urine
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01909141

Locations
Egypt
Cairo University
Cairo, Egypt
Sponsors and Collaborators
Cairo University
Investigators
Principal Investigator: Ghada Abdel Fattah Abdel Moety, lecturer Cairo University
  More Information

No publications provided

Responsible Party: Ghada Abdel Fattah, lecturer of Obstetrics and Gynecology-Cairo University, Cairo University
ClinicalTrials.gov Identifier: NCT01909141     History of Changes
Other Study ID Numbers: fem2013
Study First Received: July 15, 2013
Results First Received: February 3, 2015
Last Updated: February 19, 2015
Health Authority: Egypt: Cairo University-Faculty of Medicine

Keywords provided by Cairo University:
letrozole
clomiphene citrate
pioglitazone
metformin
ovulation induction
PCOS

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Physiological Effects of Drugs
Reproductive Control Agents
Adnexal Diseases
Cysts
Endocrine System Diseases
Genital Diseases, Female
Gonadal Disorders
Neoplasms
Ovarian Cysts
Ovarian Diseases
Citric Acid
Clomiphene
Enclomiphene
Follicle Stimulating Hormone
Letrozole
Metformin
Methyltestosterone
Pioglitazone
Testosterone
Testosterone 17 beta-cypionate
Testosterone enanthate
Testosterone undecanoate
Zuclomiphene
Anabolic Agents
Androgens
Anticoagulants
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Aromatase Inhibitors

ClinicalTrials.gov processed this record on March 03, 2015