Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001915-63 | EudraCT Number |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Oxford Fertility Limited, United Kingdom | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The fertility treatment in vitro fertilisation (IVF), sometimes including intra-cytoplasmic sperm injection (ICSI), involves the creation of embryos in a laboratory. These embryos are then transferred into the womb of the patient with the hope of a resulting pregnancy and live birth. Embryos can also be cryopreserved (frozen) and stored, and then later replaced in a cycle called frozen embryo transfer (FET). There are several methods of preparing the patient's womb to receive the frozen-thawed embryo(s) but commonly embryos are replaced during a medicated cycle. Usually oestrogen and progesterone are administered to prepare the womb lining for embryo transfer at the appropriate time, and in addition a drug called a GnRH antagonist is administered to prevent a women's own hormones from interfering with this process as it is thought this might lead to higher numbers of cycles being cancelled. However, there is some suspicion that this drug (GnRH antagonist) may not be required and that women are using this drug unnecessarily.
Some clinics do not use GnRH antagonists in FET cycles, but the investigators do not know if they have higher rates of cancelled cycles as a result.
This pilot study aims to compare cycles of medicated FET using oestrogen and progesterone, either with or without pituitary suppression in the form of GnRH antagonist (Cetrotide), in patients over the next 18 months who are planning FET cycles at Oxford Fertility, UK to find out if both give the same chance of having a baby, which treatment is better for patients and to assess the feasibility of undertaking a future larger study. Cetrotide is a marketed and well-known medication and any risk or serious adverse effects are unlikely. The study is an open label prospective randomised controlled trial. Funding for the medication (Cetrotide) is provided by Oxford Fertility.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No GnRH antaogonist | Experimental | Cetrorelix Acetate (NOT given) Daily 0.25mg Subcutaneous injection for 7 days |
|
| Standard GnRH antoagonist | Active Comparator | Cetrorelix Acetate (control) Daily 0.25mg Subcutaneous injection for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetrorelix Acetate | Drug | Used a standard |
|
| Measure | Description | Time Frame |
|---|---|---|
| Live Birth Rate | Livebirth rate per FET treatment cycle | To treatment or pregnancy end (up to 9 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Cancellation rate | Number of cycles cancelled over number of treatment cycles started | Through study completion (18 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | Defined as number of intrauterine pregnancies with at least one fetal heart visible on an early pregnancy ultrasound scan per treatment cycle. | To treatment or pregnancy end (up to 9 months) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oxford Fertility | Oxford | OX4 2HW | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C062876 | cetrorelix |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided