Clinical trial NCT04939376: Uterine Lesions and Their Association to Invitro Fertilization(IVF) or Intracytoplasmic Sperm Injection(ICSI) Outcome
Official title: Association Between Uterine , Intracavitary , Cervical and Cervical Canal Lesions With in Vitro Fertilization/Intracytoplasmic Sperm Injection(IVF/ICSI) Outcome.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: IVF
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-06-25
Enrollment: 122
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women between 18 and 38 years old.

* An indication for IVF/ICSI..
* Women with BMI between 18.5 : 29.9 .

Brief summary: 1. To study the effect of uterine wall , intracavitary , cervical as well as cervical canal lesion on the outcome of IVF/ICSI cycle.
2. To establish a score for prediction of IVF/ICSI cycle success .

Detailed description: IVF is one of the most successful treatment of fertility, (1) however, several IVF cycles fail to achieve pregnancy (2).failure defined as three or more failed attempts of ICSI (3). Implantation failure is a complex in nature, may be due to structural or functional causes (3, 4).

that previously undiagnosed, misinterpreted initial diagnoses, or subtle newly added intrauterine abnormalities may be a significant cause of IVF failure (5, 6), studies say that intra-uterine pathologies represent 40-50 % of causes of ICSI failure (7, 8), hysteroscopic removal of endometrial polyps, submucous fibroids, uterine septum, or intrauterine adhesions could increase the pregnancy rate (9). so, Evaluation of the uterine cavity may become a routine investigation before assisted reproductive technology(ART) procedures (10).

In this study, we evaluate the relationship between the different uterine and cervical pathologies and decreased live birth rate.

Eligibility criteria: Inclusion Criteria:

* Women between 18 and 38 years old.

  * An indication for IVF/ICSI..
  * Women with BMI between 18.5 : 29.9 .
  * Women with normal antimullerian hormone(AMH), antral follicle count(AFC) (good responders).

Exclusion Criteria:

Refusal to join the study.

* Women with age less than 18 and more than 38 .
* Women with BMI less than 18.5 and more than 30 .
* Untreated tubal hydrosalpinges.
* Poor responders as assessed by AFC 4 or less ,AMH O.8 ng/dl (nice 2013).

Primary outcomes:
measure: Pregnancy rate
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Momen Kamel, Prof.dr
role: STUDY_DIRECTOR
References:
citation: Rai R, Regan L. Recurrent miscarriage. Lancet. 2006 Aug 12;368(9535):601-11. doi: 10.1016/S0140-6736(06)69204-0.
citation: Dicker D, Ashkenazi J, Feldberg D, Farhi J, Shalev J, Ben-Rafael Z. The value of repeat hysteroscopic evaluation in patients with failed in vitro fertilization transfer cycles. Fertil Steril. 1992 Oct;58(4):833-5. doi: 10.1016/s0015-0282(16)55338-2.
citation: Levi Setti PE, Colombo GV, Savasi V, Bulletti C, Albani E, Ferrazzi E. Implantation failure in assisted reproduction technology and a critical approach to treatment. Ann N Y Acad Sci. 2004 Dec;1034:184-99. doi: 10.1196/annals.1335.021.