Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility

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Brief Title

Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility

Official Title

Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Women With Infertility Problems

Brief Summary

      The study will describe the effectiveness of ovarian stimulation in correlation with female
      infertility causes in a Lebanese population: a comparative study using 5 protocols of
      ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C"
      multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH
      antagonist and agonist) and the outcomes of ICSI. This comparative study will help clinicians
      to select the relevant protocol of ovarian stimulation related to the female infertility
      disorders.
    

Detailed Description

      One in six couples worldwide is affected by infertility, which defined as the inability to
      conceive after one year or more of regular and unprotected intercourse. It has been stated
      that 48.5 million couples in the world, with unprotected coitus, suffer from infertility. In
      about 50% of them, the infertility is due to female factors and diseases associated with the
      female reproductive system. Epidemiological studies show that 10 to 15% of all married
      couples are estimated to have infertility problems in the Middle East. Lebanon, in
      particular, is characterized with traditional and westernized lifestyles; It has high rates
      of smoking and caffeine intake, pollution and high rates of consanguinity marriage (11 to
      17%), which affect considerably the conception rate.

      The desire to procreate is naturally present in women all over the world. Due to various
      advances in medical procreation techniques, it has become possible for many women to realize
      their hope. Women were more likely to be psychologically distressed to infertility and suffer
      from poor quality of life more than men once they are diagnosed as infertile.

      The causes of female infertility can have a genetic, anatomical or physiological origin.
      Among the most common genetic causes of female infertility are the chromosomes abnormalities:
      the numbers of X chromosomes, homogeneous or mosaic; other abnormalities are reciprocal
      translocations, Robertsonian translocations, inversions, supernumerary markers or
      abnormalities of the X chromosome structure. In such cases, no treatment and procreation
      require an egg donation. But the main causes of female infertility are physiological and
      anatomical, such as ovulatory disorders (25%), endometriosis (15%), pelvic adhesions (12%),
      tubal blockage (11%), other tubal abnormalities (11%), hyperprolactinemia (7%) and some minor
      causes. In addition, leiomyomas, fibroma, polyps, and tubal disease, may reduce fertility. In
      addition came the environmental factors (drugs, pesticides, food, tobacco ...) and there is
      an increase in the percentage of infertile women with advancing female age. A French national
      survey on lifestyles and toxic factors in infertile couples showed that in women, tobacco
      generates a risk twice as high as being infertile, a decrease in the ovarian reserve where
      the level of anti-Mullerian hormone (AMH) decreases, irregular short cycles and dysmenorrhea
      are also found in smokers. In addition, products contained in tobacco such as cotinine,
      cadmium and hydrogen peroxide are found in the follicular fluid and would be responsible for
      an alteration of the recovery of oocyte meiosis.

      Couples who have problems with conception are referred to a medically assisted procreation
      (MAP) for fertility treatments. These treatments can be very stressful both psychologically
      and physically. Indeed, the numerous medical appointments and examinations, as well as the
      many bereavements and failures, experienced following repeated attempts at conception can to
      consume the married, social and professional life of couples. In addition, fertility issues
      require significant financial resources to cover the costs of fertility treatments, but also
      those related to the maternal and fetal complications of pregnancy, which are more frequent
      in the case of MAP pregnancies than in spontaneous conception.

      Control of the ovarian stimulation is the key component of assisted reproductive technologies
      (ART) that have shifted the clinical practice of natural mono-follicular cycles into
      multi-follicular stimulated cycles. The increase in the number of follicles, and consequently
      the number of oocytes recovered, improved pregnancy rates in women undergoing In Vitro
      Fertilization (IVF) / Intra-Cytoplasmic Sperm Injection (ICSI), not only by increasing the
      number of available embryos but also by allowing embryo culture extended and allowing the
      selection of higher quality embryos to be transferred. However, several studies have
      addressed the issue of the optimal number of oocytes recovered following controlled ovarian
      stimulation (COS) for IVF / ICSI and demonstrated that the ovarian response is independently
      related to Live Birth Rate (LBR) after IVF / ICSI.

      Many new treatment modalities for ovarian stimulation have been introduced over the years -
      often with insufficient evidence of safety and efficacy - using different compounds and
      regimens for ovarian stimulation, triggering oocyte maturation, interventions preceding
      stimulation supplementation phase. The most important clinical challenge is to find the right
      balance between improving the chances of success (birth of a healthy child), a reasonable
      cost, acceptable discomfort for the patient, and a minimal complication rate. New
      developments make ovarian stimulation less intense and more individualized. The choice of the
      ovarian stimulation protocol is one of the most important steps in IVF/ICSI treatment.

      This study aims to identify and evaluate ovarian stimulation protocols applied to different
      patients with different causes of female infertility prior to medically assisted procreation
      techniques in order to know if there is a relationship between a given protocol and the
      result obtained for each class of infertility. Therefore, 360 ICSI in 200-300 couples will be
      studied in order to evaluate the link between ovarian stimulation protocols and outcomes of
      ICSI.

      The population will be divided into 3 groups:

        1. Group "OD" for ovulation disorders caused by endocrine disorders such as the polycystic
           ovarian syndrome (PCOS) and/or premature ovarian failure (POF)

        2. Group "TD" for tubal disorders caused by previous ectopic pregnancy, salpingectomy,
           tubal obstruction and/or hydrosalpinx

        3. Group "UCD" for uterine and cervical disorders caused by fibroids, endometriosis,
           infection and/or congenital uterine anomaly (CUA)
    


Study Type

Interventional


Primary Outcome

Ovulation Induction

Secondary Outcome

 fertilization rate

Condition

Female Infertility

Intervention

Human Chorionic Gonadotropin (hCG)

Study Arms / Comparison Groups

 Protocol "A"
Description:  Protocol with gonadotropins alone without agonist or antagonist:
Gonadotropin treatment begins after spontaneous menses. The gonadotropins (e.g. Menopur, 150-225IU) are injected daily from D2/3 of the cycle (Gonadotropin dose varies based on the follicular response). The moment to trigger ovulation by administration of HCG (e.g. Ovitrelle or Pregnyl, 10.000IU) is determined by monitoring ovulation (folliculogenesis) approximately 14 days after gonadotropins regimen and the presence of at least 3 follicles with 18 mm sizes and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

200

Start Date

February 1, 2018

Completion Date

December 30, 2021

Primary Completion Date

August 22, 2019

Eligibility Criteria

        Inclusion Criteria:

          -  must not show any of the excluded criteria

          -  Patients affected by female infertility due to particularly Ovulatory Disorder,
             Premature Ovarian Failure, Polycystic Ovary Syndrome, Tubal Origin, Ectopic Pregnancy,
             Salpingitis, Tubal Block/Occlusion, Hydrosalpinx, Cervical/Vaginal, Endocrine,
             Endometriosis, Fibroids, Congenital Uterine Anomaly, Infections Uterine, and Female
             Infertility of Other Origin

          -  The selection of subjects' age must be group matched between protocols of treatment.
             Premature ovarian failure is defined as AMH (Anti Mullerian Hormone) ≤ 2 ng/mL.

          -  Willing to collaborate and to attend to the clinical follow-ups for the next three
             years

          -  Patients willing to sign informed consent

          -  Able and willing to comply with all study requirements

          -  Absence of genetic causes

          -  Medically suitable to undergo ovarian stimulation

          -  Normal serum chemistry and hematology screening tests

          -  Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV)
             serology

          -  No history of malignancy

          -  Complete history & physical examination

        Exclusion Criteria:

          -  Subjects to be excluded from the study if the male (husband) had any male infertility
             problem(s)

          -  Patients with any genetic abnormalities

          -  Patients with histories of neurologic conditions including moderate or severe head
             injury, stroke, cerebral or bone damage or malignancies, brain abnormalities, learning
             disability, major medical or psychiatric illness, and metabolic/cardiovascular disease
             or evidence of cardiac/renal damage or malignancies, alcohol, loss of weight during
             the last 2 years, chemotherapy or immunosuppressive therapy.

          -  Women aged 45 years and older, under 21 years
      

Gender

Female

Ages

21 Years - 44 Years

Accepts Healthy Volunteers

No

Contacts

Nehman Makdissy, Professor, , 

Location Countries

Lebanon

Location Countries

Lebanon

Administrative Informations


NCT ID

NCT04071574

Organization ID

LU-MC-001/18


Responsible Party

Principal Investigator

Study Sponsor

Lebanese University


Study Sponsor

Nehman Makdissy, Professor, Study Chair, Lebanese University


Verification Date

February 2021