Sub-infertility due to endometriosis MedDRA version: 14.1 Level: LLT Classification code 10016402 Term: Female infertility of pituitary-hypothalamic origin System Organ Class: 100000004872
Conditions
Interventions
Trade Name: Microgynon 30
Product Name: Combined Oral Contraceptive PIll
Pharmaceutical Form: Tablet
INN or Proposed INN: Levonorgestrel
CAS Number: 797-63-7
Other descriptive name: D-Norgestrel, Micr
Sponsors
Clinical Trials and Research Governance, University of Oxford
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Participant is willing and able to give informed consent for participation in the study. • Female aged 18 to 39 years old. • Intending to undergo treatment with a first, second or third cycle of IVF or IVF-ICSI. • Diagnosed with any degree of endometriosis. • Participants must meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: • The participant does not understand the English language, or has special communication needs. This is because it is impractical to provide, for this small scale study, information sheets and consent forms in other languages except English. • The patient has already undergone 3 or more IVF or IVF-ICSI cycles. • Patients who are already taking any medication to treat endometriosis such as progestins, OCP, GnRH agonists, danazol, mirena, etc. or who have done so within the last 3 months. • Participants who do not meet World Health Organisation Group 1 or 2 eligibility requirements for Combined Oral Contraceptive use.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Treatment response per cycle: o No. of follicles aspirated o No. of oocytes retrieved o No. of cleavage embryos (i.e. fertilized egg starting to divide) obtained o Total dose and duration of Gonadotrophin • Other cycle outcomes: o Failed cycle (negative pregnancy test) o Biochemical pregnancy only (positive pregnancy test but not clinical pregnancy) o Clinical pregnancy (defined as intra-uterine pregnancy with positive fetal heart activity at 6 gestational weeks). o Miscarriage (pregnancy loss up to 24 weeks gestation) o Stillbirth o Cycle cancellation • Number of cases of OHSS • Multiple pregnancy rate • Number of Ectopic pregnancies;Timepoint(s) of evaluation of this end point: All secondary endpoints are after treatment (with IMP) has been completed. The secondary end points are obtained during treatment cycles: Ovarian response - 24 hours after egg collection procedure Biochemical pregnancy - 2 weeks after embryo transfer Cycle cancellation - any point up to embryo transfer procedure clinical/multiple pregnancies - 4 weeks after embryo transfer | — |
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to determine if pre-treatment with oral contraceptives improves IVF or IVF-ICSI success rates (i.e. live birth rates) in patients who suffer from endometriosis.;Secondary Objective: The secondary objectives are to determine if pre-treatment with oral contracaptives improves other measures of IVF or IVF-ICSI success rates in patients who suffer from endometriosis such as • Ovarian response (how many eggs are produced) • Cancellation rate (how many IVF/IVF-ICSI cycles are cancelled) • Clinical pregnancy rate • Multiple pregnancy • Ectopic pregnancy • Ovarian hyperstimulation syndrome (OHSS);Primary end point(s): • Live birth, which is defined as the birth of a live child after 24 gestational weeks.;Timepoint(s) of evaluation of this end point: This end point may be up to approximately 30 weeks after the last study visit of each study participant (the last study visit is a pregnancy scan at around 8 weeks gestation and pregnancy can last up to 42 weeks until birth). | — |
Countries
United Kingdom
Contacts
Public ContactResearch nurse
Nuffield Dept Obstetrics & Gynaecology, University of Oxford
Outcome results
None listed